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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76280

124 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 11, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Windstone Medical Packaging, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

124 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 124

Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B.

Z-1258-2017
Recall number
Z-1258-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
45 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot numbers and Expiration dates: 80483, 1/19/2017 86796, 2/26/2018 88290, 2/7/2017 89931, 1/15/2018 98043, 9/7/2018 98446, 4/2/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 2 of 124

Angio Pack, part number AMS6711

Z-1259-2017
Recall number
Z-1259-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
174 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot numbers and Expiration dates: 100927, 7/18/2019 100928, 8/30/2019 101484, 9/23/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 3 of 124

Anterior Cervical Fusion Pack, part number AMS2502(A Anterior Cervical Fusion Pack, part number AMS2502(C

Z-1260-2017
Recall number
Z-1260-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
51 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot numbers and Expiration dates: 84343, 5/20/2018 88052, 11/11/2018 89579, 11/15/2018 89709, 12/10/2018 94934, 1/4/2019 95441, 6/3/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 4 of 124

Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 Arthroscopy Pack, part number AMS4765 Arthroscopy Pack, part number PSS1799 Arthroscopy Pack, part number PSS1845(A

Z-1261-2017
Recall number
Z-1261-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
1,081 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot Numbers and Expiration Dates 83622, 5/19/2018 84374, 5/24/2018 84729, 5/17/2017 84897, 5/26/2018 84946, 6/24/2017 85171, 6/9/2018 85363, 7/20/2017 85548, 7/15/2018 85696, 8/22/2018 85698, 7/21/2017 86510, 9/29/2018 86687, 9/5/2018 86889, 7/11/2017 86909, 9/12/2018 87156, 8/1/2018 87157, 9/5/2018 87159, 10/23/2017 87289, 10/17/2017 87978, 10/31/2017 88401, 10/7/2017 88549, 10/28/2017 88656, 12/7/2017 89219, 12/22/2017 89904, 1/23/2017 94742, 12/29/2017 95143, 12/4/2017 95284, 2/2/2018 95315, 2/20/2018 95840, 2/13/2018 96006, 1/7/2018 96469, 2/27/2018 96631, 1/8/2018 96821, 3/25/2018 96931, 2/1/2018 97751, 3/2/2018 98923, 3/20/2018 98971, 9/19/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 5 of 124

Arthroscopy Pack, part number AMS6559

Z-1262-2017
Recall number
Z-1262-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
60 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot Number and Expiration date 101247, 10/9/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 6 of 124

Augmentation Pack, part number AMS6370

Z-1263-2017
Recall number
Z-1263-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
60 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101499, 10/13/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 7 of 124

Basic Extended Pack, part number AMS4421(A Basic Extended Pack, part number AMS4421(B

Z-1264-2017
Recall number
Z-1264-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
170

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84855, 8/6/2018 88319, 9/5/2018 88950, 11/15/2018 95760, 1/26/2019 96235, 5/14/2019 98080, 6/19/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 8 of 124

Basic Face Kit, part number PS517A(D

Z-1265-2017
Recall number
Z-1265-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
965 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 81973, 5/29/2018 82332, 5/13/2018 84698, 2/10/2018 84985, 8/6/2018 85899, 8/26/2018 86370, 8/1/2018 86729, 12/26/2018 89108, 11/15/2018 89302, 12/25/2018 89652, 11/19/2018 94627, 1/11/2019 95899, 5/21/2019 96504, 5/5/2019 97666, 6/26/2019 97832, 6/13/2019 99264, 9/3/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 9 of 124

Basic Kit, part number CMP1109(A

Z-1266-2017
Recall number
Z-1266-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
216 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84274, 5/14/2018 85771, 7/29/2018 86323, 9/5/2018 87540, 9/30/2018 88763, 12/2/2018 89683, 11/16/2018 95028, 1/5/2019 96659, 5/12/2019 97882, 6/4/2019 98262, 6/15/2019 99290, 9/27/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 10 of 124

Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic Pack, part number AMS4309 Basic Pack, part number PSS1833 Basic Pack, part number PSS1833(A Basic Pack, part number PSS1848(A

Z-1267-2017
Recall number
Z-1267-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
2388 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100394, 9/15/2019 100593, 9/21/2019 100594, 10/5/2019 101063, 10/15/2019 101304, 10/23/2019 83725, 6/8/2018 84749, 9/11/2018 85159, 8/1/2018 85635, 8/6/2018 85810, 7/19/2018 86252, 9/2/2018 86440, 8/7/2018 86859, 8/18/2018 86939, 11/22/2018 87105, 9/15/2018 87269, 9/30/2018 87351, 9/15/2018 87447, 11/11/2018 87942, 9/23/2018 88172, 12/3/2018 88282, 9/7/2018 88368, 9/5/2018 88846, 12/11/2018 88887, 12/7/2018 89004, 10/8/2018 89160, 12/1/2018 89438, 11/22/2018 89512, 10/9/2018 89716, 1/9/2019 89743, 12/3/2018 89811, 12/1/2018 94572, 12/15/2018 94705, 12/15/2018 94751, 1/4/2019 94853, 1/27/2019 94935, 1/25/2019 95293, 1/26/2019 95412, 1/25/2019 95936, 1/11/2019 95974, 5/29/2019 96023, 1/16/2019 96255, 1/2/2019 96410, 3/7/2019 96566, 3/9/2019 96678, 5/24/2019 96913, 5/22/2019 97124, 5/12/2019 97410, 6/3/2019 97577, 5/1/2019 97780, 6/15/2019 98017, 6/29/2019 98312, 6/24/2019 98478, 6/29/2019 98502, 6/6/2019 98663, 6/28/2019 98633, 6/30/2019 99172, 6/12/2019 99581, 6/27/2019 99703, 9/27/2019 99843, 9/30/2019 99887, 9/11/2019 99913, 9/23/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 11 of 124

Basic Pack (1185), part number AMS6560

Z-1268-2017
Recall number
Z-1268-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
50 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101277, 10/7/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 12 of 124

Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519

Z-1269-2017
Recall number
Z-1269-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
276 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101418, 10/9/2019 84727, 5/25/2018 85308, 6/3/2018 85485, 8/5/2018 86644, 9/11/2018 87420, 9/14/2018 88160, 11/15/2018 89015, 10/8/2018 89570, 12/1/2018 94914, 1/21/2019 94920, 1/12/2019 95736, 1/2/2019 96290, 1/28/2019 96902, 8/16/2020 99041, 9/25/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 13 of 124

Basic Setup Tray, part number AMS6414

Z-1270-2017
Recall number
Z-1270-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
60 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100774, 6/9/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 14 of 124

Basic Tray, part number PSS1559(A

Z-1271-2017
Recall number
Z-1271-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
69 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101652, 10/27/2019 87941, 9/23/2018 88545, 11/7/2018 88823, 12/2/2018 95649, 1/4/2019 96354, 1/18/2019 96815, 6/17/2019 97613, 4/18/2020

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 15 of 124

Basin Pack, part number AMS2497

Z-1272-2017
Recall number
Z-1272-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
648 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84187, 5/14/2018 84938, 6/30/2018 85835, 9/12/2018 86871, 8/14/2019 87444, 9/30/2018 88377, 11/15/2018 88626, 10/8/2018 89025, 12/10/2018 89575, 1/30/2019 94929, 3/6/2019 96912, 5/5/2019 97575, 6/22/2019 97652, 9/27/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 16 of 124

Bayview Abdominoplasty Pack, part number 009079-1

Z-1273-2017
Recall number
Z-1273-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
35 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 87231, 4/19/2018 87645, 4/11/2018 89152, 4/4/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 17 of 124

Bayview Breast Pack, part number 009080-2

Z-1274-2017
Recall number
Z-1274-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
126 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84687, 2/24/2018 86231, 2/9/2018 89386, 4/8/2018 94891, 4/23/2018 95261, 4/12/2018 95968, 4/1/2018 96742, 4/23/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 18 of 124

Bleph Pack, part number AMS3325(B

Z-1275-2017
Recall number
Z-1275-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
16 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100404, 4/23/2019 80482, 5/20/2017 89885, 2/2/2017

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 19 of 124

Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Breast Augmentation Pack, part number AMS4382 Breast Augmentation Pack, part number AMS4382(A Breast Augmentation Pack, part number AMS4382(B Breast Augmentation Pack, part number AMS4392 Breast Augmentation Pack, part number PSS3430

Z-1276-2017
Recall number
Z-1276-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
1436 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100634, 9/23/2018 83241, 6/20/2017 83757, 6/1/2017 84174, 1/14/2017 84249, 1/20/2017 84496, 6/21/2017 84521, 3/19/2017 84904, 4/28/2017 84910, 1/25/2017 85071, 11/30/2017 85126, 6/28/2017 85126, 6/28/2017 85162, 1/17/2017 85565, 1/24/2017 85634, 6/11/2017 85820, 3/25/2017 85831, 6/14/2017 85985, 7/15/2017 86062, 4/21/2017 86141, 3/19/2017 86656, 7/10/2017 86797, 2/5/2018 86862, 6/18/2017 87093, 6/26/2017 87110, 8/22/2017 87747, 3/21/2017 88532, 2/11/2018 89014, 9/9/2017 89155, 12/22/2017 89244, 12/13/2017 89569, 12/3/2017 89770, 5/3/2017 89932, 7/7/2017 94601, 5/16/2017 95184, 7/29/2017 95185, 5/12/2017 95224, 5/1/2017 95265, 3/20/2018 95623, 9/22/2017 95793, 12/1/2017 96299, 5/22/2019 96563, 3/28/2018 96987, 5/21/2017 97563, 12/22/2017 97564, 3/30/2018 97902, 2/9/2018 98436, 3/7/2018 98445, 12/25/2018 98900, 2/28/2018 98937, 9/12/2018 98980, 2/3/2018 99258, 3/8/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 20 of 124

Breast Pack, part number AMS3238(A Breast Pack, part number AMS4419(A Breast Pack, part number AMS4419(B Breast Pack, part number AMS5750 Breast Pack, part number AMS5750(A Breast Pack, part number AMS6120 Breast Pack, part number PSS1784(B Breast Pack, part number PSS2272(A

Z-1277-2017
Recall number
Z-1277-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
369 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100106, 6/21/2019 100129, 9/30/2019 100132, 6/17/2019 100505, 10/6/2019 100805, 9/21/2019 85140, 7/28/2018 86315, 11/19/2018 87053, 9/12/2018 87623, 8/10/2019 87945, 10/29/2018 88185, 12/1/2018 88827, 10/10/2018 89726, 12/10/2018 94942, 1/10/2019 96754, 5/20/2019 97548, 5/19/2019 98079, 6/1/2019 98319, 6/24/2019 99056, 6/27/2019 99157, 6/15/2019 99711, 9/4/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 21 of 124

Breast Recon Pack, part number AMS5698 Breast Recon Pack, part number AMS5698(A

Z-1278-2017
Recall number
Z-1278-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
96 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100592, 9/7/2019 96541, 6/16/2019 97532, 5/7/2019 97836, 6/4/2019 98247, 6/15/2019 98788, 6/29/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 22 of 124

Brow Pack, part number PSS1785(C

Z-1279-2017
Recall number
Z-1279-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
36 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 85694, 9/29/2018 88886, 11/18/2018 89480, 12/11/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 23 of 124

Catheter Pack, part number AMS4399(A

Z-1280-2017
Recall number
Z-1280-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
1116 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84598 4/16/2017 84599 5/8/2018 85277 5/11/2018 85342 5/17/2018 85456 6/3/2018 85629 6/11/2018 85630 8/21/2018 87145 10/15/2018 89443 8/23/2018 89892 11/30/2018 95180 8/24/2018 95298 11/21/2018 95789 11/11/2018 96424 12/26/2018 96494 12/17/2018 96945 3/11/2019 97753 4/3/2019 97817 4/12/2019 98124 4/18/2019 98703 5/23/2019 98704 6/7/2019 98940 6/30/2019 99561 6/17/2019 99900 6/29/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 24 of 124

Chest Breast Drape, part number AMS5853

Z-1281-2017
Recall number
Z-1281-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
60 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100183, 5/4/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 25 of 124

C-Tray Pack, part number PSS2707(A

Z-1282-2017
Recall number
Z-1282-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
66 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84507, 9/18/2017 98125, 1/1/2018 98289, 6/12/2019 98579, 1/29/2018 98645, 1/26/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 26 of 124

Custom Breast Augmentation Pack, part number PSS2455(D

Z-1283-2017
Recall number
Z-1283-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
229 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100294, 5/29/2018 84142, 5/25/2017 85025, 5/25/2017 88222, 5/25/2017 88310, 5/25/2017 89226, 5/25/2017 96139, 7/6/2017 96969, 7/30/2017 97625, 7/27/2017

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 27 of 124

Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom Pack, part number AMS5643(A Custom Pack, part number AMS6012 Custom Pack, part number AMS6383 Custom Pack, part number PSS2135(B Custom Pack, part number PSS2798(B Custom Pack, part number PSS2798(C Custom Pack, part number PSS3463

Z-1284-2017
Recall number
Z-1284-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
4155 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100084, 10/2/2019 100678, 10/22/2019 100683, 10/13/2019 100700, 9/5/2019 100771, 7/9/2019 100772, 7/23/2019 101188, 9/6/2019 101555, 9/9/2019 84253, 5/12/2018 84254, 5/25/2018 84377, 9/10/2018 84493, 5/28/2018 84494, 5/28/2018 84495, 6/22/2018 84681, 7/22/2018 84682, 7/29/2018 84853, 7/22/2018 84919, 6/3/2018 86006, 8/22/2018 86135, 9/29/2018 86853, 10/31/2018 87162, 8/10/2019 87171, 8/20/2018 87229, 10/5/2018 87582, 12/28/2018 87615, 12/17/2018 88006, 9/23/2018 88227, 9/5/2018 88559, 11/14/2018 88573, 11/12/2018 88574, 11/14/2018 88692, 2/28/2018 88693, 12/9/2018 88899, 11/24/2018 89221, 12/7/2018 89554, 12/9/2018 89555, 1/6/2019 89762, 1/10/2019 94731, 11/12/2018 95058, 1/18/2019 95061, 1/13/2019 95477, 12/7/2018 95510, 1/25/2019 95631, 3/7/2019 95654, 1/10/2019 95874, 6/27/2019 96054, 1/13/2019 96361, 3/10/2019 96458, 1/25/2019 96477, 1/25/2019 96478, 6/23/2019 96834, 6/10/2019 96988,6/9/2019 97000, 6/29/2019 97166, 5/11/2019 97547, 5/7/2019 97820, 6/7/2019 98230, 6/8/2019 98588, 6/7/2019 98753, 6/3/2019 99515, 9/21/2019 99516, 9/30/2019 99564, 9/8/2019 99603, 10/4/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 28 of 124

Custom Pack - with Introducer Kit, part number TVS4011NI(L

Z-1285-2017
Recall number
Z-1285-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
840 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 85014, 4/30/2018 85448, 7/14/2018 85937, 8/23/2018 87713, 8/9/2018 88092, 11/18/2018 89342, 10/17/2018 89974, 12/5/2018 95212, 12/3/2018 95725, 12/19/2018 96882, 12/9/2018 97051, 5/27/2019 98088, 5/2/2019 98423, 5/25/2019 98852, 5/14/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 29 of 124

Custom Venous Kit, part number TVS4024(C

Z-1286-2017
Recall number
Z-1286-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
544 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84766, 1/8/2018 85230, 1/12/2018 85938, 1/7/2018 88327, 1/6/2018 88591, 1/9/2018 96129, 1/11/2018 96256, 1/1/2018 96660, 1/2/2018 98425, 1/24/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 30 of 124

D & C Kit, part number CMP1466(A

Z-1287-2017
Recall number
Z-1287-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
136 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 85461, 8/5/2018 86216, 8/24/2018 87933, 11/15/2018 96803, 3/8/2019 97312, 5/5/2019 98203, 6/6/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 31 of 124

D & C Pack, part number AMS4796(A

Z-1288-2017
Recall number
Z-1288-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
24 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 95176, 10/20/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 32 of 124

D&C/Cysto Pack, part number PSS3257(D

Z-1289-2017
Recall number
Z-1289-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
380 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100086, 5/12/2019 85563, 8/13/2017 87345, 8/18/2017 89066, 8/8/2017 94998, 8/18/2017 95508, 8/12/2017 95667, 3/10/2017 96490, 8/5/2017 97900, 4/13/2019 99440, 4/5/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 33 of 124

Dr Bragg Vein Tray - RX, part number 007912-8

Z-1290-2017
Recall number
Z-1290-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
120 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 86735, 9/14/2017 87662, 7/12/2018 88455, 12/18/2017 95528, 1/3/2018 96110, 6/6/2018 99457, 7/1/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 34 of 124

Dr. Casey Pack, part number AMS4313(A

Z-1291-2017
Recall number
Z-1291-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
66 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 89198, 4/22/2018 94965, 3/31/2018 95296, 2/20/2018 96567, 4/18/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 35 of 124

Dr. Landi EVLT Pack, part number AMS1483(E Dr. Landi EVLT Pack, part number AMS1483(E

Z-1292-2017
Recall number
Z-1292-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
944 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100007, 2/26/2019 100008, 2/3/2019 100009, 2/10/2019 100322, 4/2/2019 101129, 2/21/2019 84854, 12/26/2017 85111, 12/1/2017 86047, 12/19/2017 86791, 5/7/2018 88616, 5/13/2018 88617, 6/11/2018 88845, 6/12/2018 89076, 10/22/2018 89175, 10/7/2018 89568, 11/9/2018 89715, 11/25/2018 94567, 10/23/2018 97120, 12/7/2018 97562, 11/27/2018 97771, 11/27/2018 98014, 11/11/2018 98014, 11/11/2018 98160, 2/22/2018 98161, 11/21/2018 98162, 11/30/2018 98494, 2/13/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 36 of 124

Dr. Newman Surgical Procedure Pack, part number PSS1689(A

Z-1293-2017
Recall number
Z-1293-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
24 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 88547, 1/7/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 37 of 124

ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214

Z-1294-2017
Recall number
Z-1294-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
390 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84530, 5/25/2018 84588, 5/12/2018 85139, 7/14/2018 85655, 8/1/2018 86310, 9/26/2018 86480, 9/3/2018 86749, 9/21/2018 87287, 8/11/2019 88184, 9/4/2018 88318, 11/19/2018 88647, 10/5/2018 89495, 9/30/2019 89589, 12/10/2018 95103, 1/2/2019 96194, 1/18/2019 96922, 5/11/2019 97787, 6/9/2019 98676, 6/27/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 38 of 124

Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part numbre PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A

Z-1295-2017
Recall number
Z-1295-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
810 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100226, 9/11/2019 101400, 10/7/2019 84373, 5/28/2018 84678, 6/8/2018 84896, 5/26/2018 84959, 7/29/2018 85470, 2/23/2017 85505, 7/23/2018 85547, 8/23/2018 85695, 7/8/2018 85846, 8/5/2018 86258, 9/19/2018 86509, 9/28/2018 86663, 8/11/2019 86686, 9/9/2018 86908, 9/13/2018 87155, 9/16/2018 87730, 7/5/2017 87968, 9/6/2018 88008, 7/1/2017 88862, 2/7/2018 89394, 11/15/2017 89546, 7/21/2017 89832, 12/29/2018 95313, 9/16/2019 95453, 1/22/2019 95880, 6/12/2019 96000, 1/6/2019 96383, 5/25/2018 96384, 5/13/2018 96923, 5/1/2019 97709, 5/1/2019 99376, 6/7/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 39 of 124

Extremity Pack (1344), part number AMS6561

Z-1296-2017
Recall number
Z-1296-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
60 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101250, 10/8/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 40 of 124

Extremity Pack-N Brunswick, part number PSS1866(A

Z-1297-2017
Recall number
Z-1297-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
10 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84476, 7/21/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 41 of 124

Eye Plastic Tray, part number PSS1931(A

Z-1298-2017
Recall number
Z-1298-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
310 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84566, 3/8/2017 85861, 7/5/2017 86513, 8/27/2017 88308, 11/30/2017 88550, 11/12/2017 88986, 11/1/2017 96822, 2/17/2018 97615, 2/5/2018 97993, 7/9/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 42 of 124

Eye Tray, part number PSS1834 Eye Tray, part number PSS1834(A

Z-1299-2017
Recall number
Z-1299-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
310 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100671, 9/28/2019 101398, 10/13/2019 84475, 5/26/2018 86027, 9/2/2018 87239, 9/5/2018 89280, 11/16/2018 95047, 1/24/2019 96991, 6/29/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 43 of 124

Facial Pack , part number AMS6501

Z-1300-2017
Recall number
Z-1300-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
24 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101262, 5/9/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 44 of 124

Facial Plastic Pack, part number AMS3327(C

Z-1301-2017
Recall number
Z-1301-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
15 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 86349, 5/22/2017 89085, 2/12/2017 101415, 4/2/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 45 of 124

Facial Tray, part number PSS1558(A

Z-1302-2017
Recall number
Z-1302-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
84 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101651, 10/15/2019 84873, 6/3/2018 87601, 8/25/2018 87884, 9/30/2018 88601, 10/9/2018 89542, 12/29/2018 95493, 1/3/2019 96353, 1/31/2019 97496, 6/29/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 46 of 124

Foot Pack, part number AMS3637

Z-1303-2017
Recall number
Z-1303-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
40 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84442, 5/17/2017 84757, 5/17/2017

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 47 of 124

General Laparoscopy Pack, part number AMS4798 General Laparoscopy Pack, part number AMS4798(A

Z-1304-2017
Recall number
Z-1304-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
36 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84121, 6/8/2018 95178, 9/28/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 48 of 124

General Pack, part number AMS2967(A General Pack, part number AMS3239(A General Pack, part number AMS3709(B General Pack, part number AMS5341 General Pack, part number AMS5694

Z-1305-2017
Recall number
Z-1305-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
1501 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100415, 9/23/2019 100737, 9/30/2019 100981, 10/20/2019 101069, 9/6/2019 101739, 10/19/2019 101816, 10/14/2019 83797, 5/12/2018 84203, 5/26/2018 84668, 5/17/2018 84793, 2/3/2019 85141, 6/8/2018 85421, 7/28/2018 85504, 8/30/2018 86008, 7/8/2018 86260, 9/9/2018 86481, 9/5/2018 86586, 9/27/2018 86774, 8/8/2018 86837, 9/12/2018 87291, 9/30/2018 87456, 9/30/2018 87754, 1/7/2019 88321, 9/6/2018 88648, 12/29/2018 88657, 12/2/2018 88764, 10/8/2018 89333, 12/25/2018 89429, 12/29/2018 94713, 12/14/2018 94739, 1/25/2019 94783, 12/16/2018 95286, 11/12/2018 95349, 1/10/2019 95432, 1/24/2019 95459, 1/21/2019 95928, 1/23/2019 95999, 3/9/2019 96009, 1/7/2019 96501, 1/6/2019 96934, 5/30/2019 97201, 5/5/2019 97338, 5/13/2019 97459, 6/4/2019 97854, 6/14/2019 98176, 6/29/2019 98263, 6/11/2019 98677, 6/3/2019 99291, 6/12/2019 99385, 6/11/2019 99682, 6/29/2019 99712, 6/5/2019 99889, 9/4/2019 99926, 9/27/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 49 of 124

General Plastic Pack, part number PSS2432(A

Z-1306-2017
Recall number
Z-1306-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
10 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 95325, 6/18/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 50 of 124

General Plastics Pack, part number 008617-1

Z-1307-2017
Recall number
Z-1307-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
465 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 85096, 12/11/2017 85458, 12/20/2017 88364, 12/27/2017 89172, 9/3/2018 95260, 9/20/2018 95790, 9/9/2018 96288, 9/18/2018 96562, 9/20/2018 97526, 9/27/2018 97560, 9/13/2018 99232, 2/1/2019 99232, 2/1/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 51 of 124

General Surgery Pack, part number PSS1380(A

Z-1308-2017
Recall number
Z-1308-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
80 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84680, 5/19/2018 85462, 8/6/2018 86849, 8/16/2018 87483, 8/11/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 52 of 124

GYN Lap Pack, part number PSS2194(B

Z-1309-2017
Recall number
Z-1309-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
5 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 97553, 4/25/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 53 of 124

GYN Pack, part number AMS4013(A

Z-1310-2017
Recall number
Z-1310-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
20 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 83798, 5/17/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 54 of 124

Hand Pack, part number AMS3640 Hand Pack, part number AMS4213(A Hand Pack, part number AMS4311(A Hand Pack, part number AMS5343 Hand Pack., part number PSS1843(A

Z-1311-2017
Recall number
Z-1311-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
102 6 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100610, 8/6/2018 84646, 5/12/2017 84692, 7/28/2017 84730, 5/18/2017 84851, 6/1/2017 84859, 2/28/2017 85509, 7/1/2017 86309, 8/26/2018 86748, 8/17/2018 86839, 8/2/2018 86937, 10/14/2017 87631, 10/5/2017 87866, 9/15/2018 88208, 4/6/2017 88209, 7/31/2017 88266, 10/29/2018 88267, 1/5/2020 88279, 1/3/2019 88402, 11/2/2017 88875, 10/31/2017 89734, 12/16/2017 94987, 3/21/2018 95112, 2/2/2018 96198, 2/10/2018 96608, 1/7/2018 97288, 2/7/2018 97796, 5/6/2018 98564, 3/19/2018 99383, 5/11/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 55 of 124

Hand Tray, part number PSS2365(F Hand Tray, part number PSS2365(G

Z-1312-2017
Recall number
Z-1312-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
1416 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84418, 1/30/2017 85478, 5/15/2017 85479, 5/21/2017 86212, 1/27/2017 86213, 1/27/2017 86630, 1/14/2017 87353, 1/24/2017 87946, 1/30/2017 88345, 2/22/2017 89564, 2/19/2017 94774, 1/17/2017 95066, 1/30/2017 95322, 1/25/2017 95854, 2/18/2017 96363, 2/10/2017 96634, 2/7/2018 97251, 2/7/2018 97325, 2/18/2018 98448, 2/10/2018 98449, 5/12/2018 98450, 10/24/2018 98451, 10/24/2018 98452, 10/31/2018 98453, 10/30/2018 98576, 10/20/2018 98577, 4/16/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 56 of 124

Head Pack, part number PSS1934(B

Z-1313-2017
Recall number
Z-1313-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
40 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 87600, 8/30/2018 87943, 11/21/2018 89456, 12/29/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 57 of 124

Head/Neck Pack, part number AMS6121

Z-1314-2017
Recall number
Z-1314-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
24 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100105, 6/21/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 58 of 124

Hernia Pack, part number AMS3859

Z-1315-2017
Recall number
Z-1315-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
228 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101167, 5/30/2019 87349, 6/20/2018 88830, 9/11/2018 89510, 11/29/2018 94616, 11/15/2018 94704, 11/24/2018 95209,11/25/2018 95934, 1/15/2019 97409, 3/6/2019 99486, 3/12/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 59 of 124

Hip Pack (1347), part number AMS6564

Z-1316-2017
Recall number
Z-1316-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
40 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101253, 10/15/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 60 of 124

HSG Pack, part number PSS3287

Z-1317-2017
Recall number
Z-1317-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
300 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 86441, 8/16/2018 87951, 12/1/2018 89639, 12/29/2018 94599, 1/21/2019 94870, 11/19/2018 99799, 10/7/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 61 of 124

Hystero Pack, part number PSS3535(A

Z-1318-2017
Recall number
Z-1318-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
32 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 85990, 8/9/2018 89525, 8/10/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 62 of 124

Hysteroscopy Pack, part number AMS4797 Hysteroscopy Pack, part number AMS4797(A Hysteroscopy Pack, part number AMS4797(B

Z-1319-2017
Recall number
Z-1319-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
130 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100452, 9/8/2019 100934, 10/6/2019 84549, 5/10/2018 86945, 3/9/2019 95425, 5/20/2019 99399, 6/16/2019 99741, 9/25/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 63 of 124

Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860

Z-1320-2017
Recall number
Z-1320-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
700 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100023, 9/22/2019 100595, 9/1/2019 84529, 5/13/2018 84584, 5/26/2018 84728, 5/25/2018 85250, 7/22/2018 85273, 7/10/2018 85645, 8/1/2018 85845, 8/19/2018 87286, 8/11/2019 87350, 9/21/2018 87967, 9/24/2018 88173, 11/11/2018 88390, 11/21/2018 88627, 12/24/2018 89082, 10/3/2018 89422, 12/16/2018 89511, 11/13/2018 94573, 11/19/2018 94941, 11/20/2018 95452, 5/6/2019 95985, 3/8/2019 97273, 5/22/2019 98169, 6/26/2019 98664, 6/25/2019 98675, 6/23/2019 99375, 6/12/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 64 of 124

Knee Pack, part number AMS4211

Z-1321-2017
Recall number
Z-1321-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
150 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 86307, 7/15/2018 86746, 8/7/2018 88245, 10/30/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 65 of 124

Knee Scope Pack, part number AMS2498(A Knee Scope Pack, part number AMS2498(B Knee Scope Pack, part number AMS2498(C

Z-1322-2017
Recall number
Z-1322-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
156 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84341, 5/27/2018 85494, 7/21/2018 86719, 9/2/2018 86872, 8/19/2018 87445, 8/2/2018 88048, 11/22/2018 89163, 11/19/2018 94930, 1/5/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 66 of 124

Laminectomy Pack, part number PSS1844(B

Z-1323-2017
Recall number
Z-1323-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
291 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 83287, 8/9/2017 87158, 7/10/2017 88004, 10/5/2017 88548, 10/14/2017 89055, 11/16/2017 89903, 12/28/2017 95142, 2/12/2018 95314, 2/9/2018 95839, 2/12/2018 96468, 3/26/2018 96630, 4/11/2018 96820, 6/12/2018 98748, 10/20/2017 99774, 6/24/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 67 of 124

Lap Band Pack, part number AMS1785(A

Z-1324-2017
Recall number
Z-1324-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
252 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 85157, 2/28/2017 86861, 2/28/2017 87419, 4/30/2017 88367, 3/31/2017 89154, 7/31/2017 94568, 7/31/2017 94919, 11/30/2017 95972, 10/31/2017 96744, 11/30/2017 97772, 11/30/2017 98016, 11/30/2017 98495, 3/31/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 68 of 124

Lap Chole Pack (6037) , part number AMS6567

Z-1325-2017
Recall number
Z-1325-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
39 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101256, 10/14/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 69 of 124

Lap Gallbladder Pack, part number AMS3707

Z-1326-2017
Recall number
Z-1326-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
225 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100414, 10/20/2019 84309, 5/14/2018 84891, 6/9/2018 85661, 7/14/2018 86668, 9/5/2018 87290, 8/9/2019 88195, 11/15/2018 94578, 12/14/2018 95117, 3/6/2019 97136, 5/29/2019 98513, 6/2/2019 99066, 6/20/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 70 of 124

Lap Minor Pack (1346), part number AMS6566

Z-1327-2017
Recall number
Z-1327-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101255, 10/8/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 71 of 124

Lap Pack, part number AMS4801

Z-1328-2017
Recall number
Z-1328-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
36 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 88798 4/20/2017 88994 4/16/2017 89895 7/19/2017 97151 7/31/2017

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 72 of 124

Lap/Pelviscopy Pack, part number PSS3256(B

Z-1329-2017
Recall number
Z-1329-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
168 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 85327, 7/14/2018 88019, 9/5/2018 88577, 12/27/2018 89638, 1/29/2019 95231, 1/12/2019 95423, 1/2/2019 96080, 6/21/2019 99559, 6/5/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 73 of 124

Laparoscopic Pack, part number AMS2499 Laparoscopic Pack, part number AMS2499(A Laparoscopic Pack, part number AMS2499(B

Z-1330-2017
Recall number
Z-1330-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
1056 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84903, 7/25/2018 85836, 8/22/2018 86720, 9/30/2018 86873, 8/16/2018 87104, 8/30/2018 88049, 10/29/2018 88170, 10/5/2018 88378, 11/15/2018 88379, 12/2/2018 89576, 11/15/2018 89577, 12/2/2018 89721, 12/17/2018 94931, 1/29/2019 94932, 1/5/2019 95274, 1/27/2019 95596, 1/13/2019 95983, 6/10/2019 96593, 5/1/2019 97448, 5/28/2019 97653, 6/17/2019 97654, 6/24/2019 97655, 6/21/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 74 of 124

Laparoscopy Pack (1184), part number AMS6562

Z-1331-2017
Recall number
Z-1331-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
28 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101251, 8/9/2017

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 75 of 124

Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy Pack, part number PSS2190(A

Z-1332-2017
Recall number
Z-1332-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
331 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100128, 9/28/2019 84856, 1/31/2019 86767, 12/22/2018 87491, 10/22/2017 88562, 10/20/2017 89958, 12/15/2018 94988, 12/5/2017 95849, 12/3/2017 96246, 3/3/2019 97441, 6/4/2019 97888, 6/16/2018 98626, 6/24/2019 98972, 7/22/2018 99473, 6/6/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 76 of 124

Lipo Pack, part AMS4420(A

Z-1333-2017
Recall number
Z-1333-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
8 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101490, 10/15/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 77 of 124

Liposuction Pack, part number AMS3323(B Liposuction Pack, part number AMS5684 Liposuction Pack, part number AMS5699

Z-1334-2017
Recall number
Z-1334-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
35 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100265, 10/8/2019 88101, 2/28/2017 96542, 6/15/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 78 of 124

Lower Extremity Pack, part number AMS4669

Z-1335-2017
Recall number
Z-1335-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
198 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date AMS4669, 85376 AMS4669, 86279 AMS4669, 87657 AMS4669, 88434 AMS4669, 95690 AMS4669, 96189 AMS4669, 96190 AMS4669, 99735 AMS4669, 100446

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 79 of 124

Lumbar Laminectomy Pack, part number AMS2501 Lumbar Laminectomy Pack, part number AMS2501(A Lumbar Laminectomy Pack, part number AMS2501(B

Z-1336-2017
Recall number
Z-1336-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
123 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 83672, 5/11/2018 84748, 6/3/2018 86722, 8/19/2018 88051, 1/7/2018 89026, 11/21/2018 89027, 12/12/2018 89882, 12/10/2018 94933, 1/29/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 80 of 124

Major Breast Pack, part number AMS3409(B

Z-1337-2017
Recall number
Z-1337-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
40 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 95427, 6/7/2017 9551, 6/12/2017 95604, 6/2/2017 96600, 10/23/2017 99890, 10/21/2017

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 81 of 124

Major Kit, part number PHC1307(A

Z-1338-2017
Recall number
Z-1338-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
85 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84334, 6/8/2018 86584, 8/7/2018 89801, 1/24/2019 96122, 3/6/2019 97375, 6/2/2019 98632, 6/3/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 82 of 124

Major Laparotomy Pack - NS, part number AMS4347

Z-1339-2017
Recall number
Z-1339-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
32 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 78636, 4/16/2017 98273, 6/10/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 83 of 124

Major Pack (1345), part number AMS6565

Z-1340-2017
Recall number
Z-1340-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
39 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101254, 10/14/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 84 of 124

Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor Pack, part number PSS3541(A

Z-1341-2017
Recall number
Z-1341-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
665 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100188, 10/19/2019 100884, 9/17/2019 84683, 5/27/2018 85122, 6/3/2018 85476, 8/17/2018 85717, 7/21/2018 86693, 9/3/2018 8695212/2/2018 87882, 11/11/2018 88612, 12/28/2018 88934, 11/28/2017 89105, 10/2/2018 89214, 11/19/2018 89473, 1/2/2019 89751, 1/21/2019 95234, 1/7/2019 96087, 1/9/2019 97240, 4/5/2018 97339, 5/13/2019 97525, 6/19/2019 97802, 6/10/2018 97958, 6/4/2019 98056, 6/29/2019 98591, 6/30/2019 99911, 9/24/2019 99918, 6/20/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 85 of 124

Minor Procedure Pack, part number AMS4799

Z-1342-2017
Recall number
Z-1342-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
365 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100253, 3/31/2018 88213, 4/30/2017 88671, 4/13/2017 88876, 4/22/2017 89097, 4/30/2017 89205, 4/15/2017 94555, 3/31/2017 94588, 3/31/2017 95305, 3/31/2017 96331, 10/26/2017 97150, 11/30/2017 98711, 11/30/2017

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 86 of 124

Minor Tray, part number AMS2685

Z-1343-2017
Recall number
Z-1343-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
80 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84344, 6/2/2018 85357, 7/17/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 87 of 124

Minor/General/Ortho Pack, part number PSS3258(B

Z-1344-2017
Recall number
Z-1344-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
140 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100087, 9/21/2019 85714, 7/29/2018 94551, 1/29/2019 95225, 1/30/2019 96081, 6/4/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 88 of 124

Morris Hysto Pack, part number PSS3198(A

Z-1345-2017
Recall number
Z-1345-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
156 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101121, 10/5/2019 101680, 10/27/2019 83882, 7/8/2018 87088, 8/16/2018 87496, 9/24/2018 88351, 11/11/2018 89549, 12/22/2018 94996, 1/30/2019 97899, 6/15/2019 98769, 6/25/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 89 of 124

Morris Lap Pack, part number PSS3199(A

Z-1346-2017
Recall number
Z-1346-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
25 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84487, 8/24/2018 94598, 11/11/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 90 of 124

Nasal Pack, part number PSS2186

Z-1347-2017
Recall number
Z-1347-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
16 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 98651, 5/30/2017

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 91 of 124

Newport Coast Basic Pack, part number 007484-1

Z-1348-2017
Recall number
Z-1348-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
152 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101006, 9/30/2019 88154, 11/11/2018 88970, 1/5/2019 96163, 1/23/2019 96254, 5/23/2019 97206, 6/29/2019 99295, 6/24/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 92 of 124

Ocular Plastic Pack, part number AMS3868(A

Z-1349-2017
Recall number
Z-1349-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
100 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 86489, 8/9/2017 88198, 8/29/2017 88412, 8/20/2017 88868, 12/25/2017

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 93 of 124

Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AMS4596(A Open Procedure Pack, part number AMS4596(B

Z-1350-2017
Recall number
Z-1350-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
1125 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100206, 6/1/2018 100248, 7/9/2018 100438, 7/19/2018 100439, 8/29/2018 100853, 9/15/2018 86832, 10/10/2017 88268, 10/4/2017 89377 ,11/9/2017 89378, 12/9/2017 94967, 12/31/2017 95888, 1/5/2018 96199, 2/11/2018 97018, 1/9/2018 97019, 2/17/2018 97146, 4/28/2018 97301, 3/22/2018 97478, 6/13/2018 98189, 5/20/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 94 of 124

Open Procedure Pack II, part number RMS1740(A

Z-1351-2017
Recall number
Z-1351-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
160 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84814, 2/6/2018 86168, 8/30/2018 88510, 12/1/2018 89151, 1/21/2019 95032, 1/13/2019 96555, 6/1/2019 98134, 6/6/2019 99502, 9/17/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 95 of 124

Opgrande Hand Pack, part number AMS4767

Z-1352-2017
Recall number
Z-1352-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
48 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84376, 5/25/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 96 of 124

Orbitofacial Pack, part number AMS5850(A

Z-1353-2017
Recall number
Z-1353-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
60 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 98286, 6/5/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 97 of 124

Ortho Minor Pack, part number AMS3710(A

Z-1354-2017
Recall number
Z-1354-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
664 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100234, 9/8/2019 84944, 6/4/2018 85366, 7/23/2018 85662, 9/29/2018 86669, 9/15/2018 87127, 11/21/2018 89042, 12/12/2018 89735, 11/12/2018 95813, 1/28/2019 96010, 1/26/2019 97466, 5/28/2019 98514, 6/30/2019 99386, 6/10/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 98 of 124

Ortho Pack, part number PSS3466(A

Z-1355-2017
Recall number
Z-1355-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
84 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 88900, 10/10/2018 94563, 1/4/2019 95875, 1/6/2019 96652, 3/8/2019 97170, 5/5/2019 98072, 5/1/2019 98589, 10/12/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 99 of 124

Pacemaker Kit, part number AMS4281 Pacemaker Kit, part number AMS4281(A Pacemaker Kit, part number AMS4281(C Pacemaker Kit, part number AMS4281(D

Z-1356-2017
Recall number
Z-1356-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
561 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 80492, 5/3/2018 82502, 6/8/2018 85302, 7/12/2018 88153, 11/13/2018 89116, 12/10/2018 89318, 11/22/2018 95070, 1/29/2019 95088, 11/14/2018 95580, 1/4/2019 95581, 1/4/2019 95582, 1/11/2019 95583, 1/24/2019 97115, 6/12/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 100 of 124

Percutaneous Entry Kit, part number TVS4022(D Percutaneous Entry Kit , part number TVS4022(E Percutaneous Entry Kit, part number TVS4022(F

Z-1357-2017
Recall number
Z-1357-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
350 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 80492, 5/3/2018 82502, 6/8/2018 85302, 7/12/2018 88153, 11/13/2018 89116, 12/10/2018 89318, 11/22/2018 95070, 1/29/2019 95088, 11/14/2018 95580, 1/4/2019 95581, 1/4/2019 95582, 1/11/2019 95583, 1/24/2019 97115, 6/12/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 101 of 124

Peri GYN, part number PSS2193(A

Z-1358-2017
Recall number
Z-1358-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
120 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 86291, 9/19/2017 87829, 10/7/2017 96967, 4/21/2018 98214, 6/19/2018 99585, 9/28/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 102 of 124

Plastic General Pack, part number AMS4215

Z-1359-2017
Recall number
Z-1359-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
55 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 86311, 9/26/2018 86750, 12/21/2019 88475, 12/10/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 103 of 124

Plastic Kit, part number CMP1084(C

Z-1360-2017
Recall number
Z-1360-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
580 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 86626, 9/3/2017 87202, 9/16/2017 87481, 9/9/2017 87924, 9/17/2017 88217, 10/31/2017 88819, 10/27/2017 89271, 10/11/2017 89539, 12/7/2017 95831, 1/9/2018 96460, 4/12/2018 98055, 6/30/2018 98962, 6/22/2018 99088, 9/15/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 104 of 124

Plastic Pack, part number PSS2462 Plastic Pack, part number PSS3319 Plastic Pack, part number PSS3319(A

Z-1361-2017
Recall number
Z-1361-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101684, 8/21/2018 84576, 5/19/2017 87746, 10/15/2017 88702, 11/13/2017 89228, 10/1/2017 95000, 1/16/2018 96841, 1/8/2018 97168, 6/11/2018 97250, 7/15/2018 99100, 6/9/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 105 of 124

Plastic Surgery Pack, part number AMS5685

Z-1362-2017
Recall number
Z-1362-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
120 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100266, 9/8/2019 100267, 9/21/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 106 of 124

Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack, part number AMS3785(B Podiatry Pack, part number AMS3785(C Podiatry Pack, part number AMS4011(A Podiatry Pack, part number PSS3422(A

Z-1363-2017
Recall number
Z-1363-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
2018 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 83685, 5/17/2018 84193, 5/20/2018 84520, 5/25/2018 84823, 6/30/2018 84892, 6/16/2018 85953, 7/29/2018 85991, 7/15/2018 85992, 7/23/2018 86060, 7/11/2018 86346, 7/30/2018 86419, 8/25/2018 87109, 8/15/2018 87789, 9/23/2018 87886, 10/29/2018 88300, 9/23/2018 88301, 9/30/2018 88313, 9/23/2018 88331, 10/11/2018 88332, 10/22/2018 88333, 10/25/2018 88630, 11/17/2018 88630, 11/17/2018 88707, 11/11/2018 88937, 6/28/2019 89028, 12/13/2018 95275, 1/19/2019 95598, 12/27/2018 95803, 1/11/2019 95989, 1/26/2019 96597, 3/24/2019 96916, 3/5/2019 97452, 3/21/2019 97580, 4/15/2019 97781, 4/22/2019 98022, 5/31/2019 98314, 5/29/2019 98668, 6/11/2019 98908, 7/24/2019 99873, 10/1/2019 99874, 6/4/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 107 of 124

Reduction Mammoplasty Pack, part number AMS4380 Reduction Mammoplasty Pack, part number AMS4380(B

Z-1364-2017
Recall number
Z-1364-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
35 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84592, 11/18/2017 85070, 11/8/2017 86795, 2/27/2018 89930, 9/1/2018 99074, 11/27/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 108 of 124

Robotic Pack, part number AMS4389

Z-1365-2017
Recall number
Z-1365-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
57 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101356, 9/9/2019 83800, 3/13/2018 89442, 10/3/2018 94546, 11/21/2018 95128, 6/30/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 109 of 124

Set Up Pack, part number PSS3574(A

Z-1366-2017
Recall number
Z-1366-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
820 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100490, 8/7/2019 84969, 5/27/2018 85341, 6/15/2018 85566, 6/8/2018 86926, 8/2/2018 86927, 7/16/2018 87263, 10/10/2018 89647, 11/23/2018 89913, 10/2/2018 94889, 11/28/2018 95156, 11/14/2018 95674, 12/27/2018 96088, 1/25/2019 96849, 3/7/2019 96990, 5/7/2019 97637, 5/27/2019 98073, 5/23/2019 98373, 5/30/2019 99444, 6/24/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 110 of 124

Set-Up Pack, part number PSS1305(C

Z-1367-2017
Recall number
Z-1367-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
1275 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100280, 9/22/2019 101104, 9/14/2019 84089, 6/29/2018 85293, 7/29/2018 85807, 8/21/2018 86209, 9/23/2018 86427, 8/9/2018 86627, 8/11/2019 87734, 9/29/2018 87934, 9/7/2018 87935, 11/21/2018 87936, 12/25/2018 87937, 12/29/2018 89476, 1/28/2019 95646, 1/10/2019 96062, 1/16/2019 96463, 3/8/2019 96464, 6/22/2019 96465, 5/28/2019 96466, 5/29/2019 96807, 6/6/2019 97610, 6/19/2019 97611, 6/17/2019 97878, 9/25/2019 97878, 9/25/2019 99195, 9/14/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 111 of 124

Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AMS2496(C Shoulder Arthroscopy Pack, part number AMS2609 Shoulder Arthroscopy Pack, part number AMS3857 Shoulder Arthroscopy Pack, part numbr AMS4766 Shoulder Arthroscopy Pack, part number AMS4766(A Shoulder Arthroscopy Pack, part number AMS4766(B

Z-1368-2017
Recall number
Z-1368-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
606 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100823, 10/13/2019 100856, 9/5/2019 84375, 5/20/2018 84747, 7/23/2018 85059, 7/21/2018 85549, 7/13/2018 85838, 8/1/2018 86718, 9/5/2018 87103, 9/12/2018 87106, 9/15/2018 87277, 8/10/2019 87347, 6/22/2018 87916, 6/22/2019 87962, 11/15/2018 88047, 9/4/2018 88376, 12/29/2018 89418, 11/12/2018 94736, 1/21/2019 95273, 6/12/2019 96914, 6/15/2019 97450, 5/11/2019 98491, 9/27/2019 98503, 6/6/2019 99369, 9/27/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 112 of 124

Shoulder Pack, part number AMS2936 Shoulder Pack, part number AMS3638 Shoulder Pack, part number AMS3711(B Shoulder Pack, part numbere AMS4212 Shoulder Pack, part number AMS6460 Shoulder Pack, part numberPSS1852(A

Z-1369-2017
Recall number
Z-1369-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
875 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100412, 8/14/2018 100837, 10/19/2019 101181, 10/9/2019 83278, 5/27/2018 83634, 5/20/2017 84945, 6/24/2017 85147, 7/28/2017 85150, 7/15/2018 85258, 6/10/2018 85541, 7/14/2018 85554, 7/2/2018 85555, 7/7/2018 86259, 7/2/2017 86308, 9/20/2018 86488, 10/29/2018 86512, 9/28/2018 86688, 11/16/2019 86747, 8/3/2018 87122, 10/7/2017 87798, 10/28/2017 88399, 10/19/2017 88404, 11/20/2018 89040, 12/14/2017 89088, 12/10/2018 89598, 11/18/2018 89887, 12/16/2018 95111, 12/12/2017 95287, 6/15/2019 95811, 2/23/2018 96607, 1/7/2018 97133, 2/7/2018 97290, 5/22/2019 98325, 3/26/2018 98687, 6/14/2019 99065, 6/13/2018 99548, 9/27/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 113 of 124

Spine Pack , part number AMS3753(A Spine Pack, part number AMS3783(A Spine Pack, part number AMS3783(B Spine Pack, part number AMS6472

Z-1370-2017
Recall number
Z-1370-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
286 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100932, 1/28/2018 101802, 11/13/2018 84360, 6/3/2017 85663, 7/20/2017 86544, 7/4/2017 87130, 8/24/2017 87382, 10/31/2017 87650, 9/9/2017 87669, 8/6/2017 88935, 11/11/2017 94580, 2/18/2017 97848, 12/11/2017

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 114 of 124

Stem Pack, part number AMS5166

Z-1371-2017
Recall number
Z-1371-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
16 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 96521, 1/31/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 115 of 124

Surgical Pack, part number PSS3540(A

Z-1372-2017
Recall number
Z-1372-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
88 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84577, 8/18/2018 88021, 12/1/2018 95560, 1/18/2019 95673, 1/27/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 116 of 124

Total Hip Pack, part number PSS2956

Z-1373-2017
Recall number
Z-1373-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
33 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100303, 1/27/2019 87238, 1/13/2018 88604, 2/8/2018 89547, 2/28/2018 95330, 11/12/2018 96075, 1/5/2019 96166, 1/14/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 117 of 124

Total Joint Pack, part number 006358-6

Z-1374-2017
Recall number
Z-1374-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
14 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 84847, 2/28/2017 87391, 3/31/2017 89385, 6/17/2017 89960, 6/8/2017 94833, 6/26/2017 97859, 6/23/2017

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 118 of 124

Total Knee Pack (15710), part number AMS6563

Z-1375-2017
Recall number
Z-1375-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
60 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101282, 6/12/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 119 of 124

Transvaginal Pack, part number CMP1767

Z-1376-2017
Recall number
Z-1376-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
650 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 85689, 7/24/2018 85859, 8/1/2018 86125, 11/14/2018 89073, 11/25/2018 89074, 11/22/2018 89211, 12/11/2018 89212, 12/3/2018 89273, 6/15/2019 97315, 5/6/2019 97489, 6/27/2019 98343, 6/10/2019 98344, 9/9/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 120 of 124

Universal Pack, part number AMS2036

Z-1377-2017
Recall number
Z-1377-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
15 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 87597, 2/28/2017 88967, 4/30/2017

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 121 of 124

Upper Extremity Pack, part number AMS4670 Upper Extremity Pack, part number AMS4670(A

Z-1378-2017
Recall number
Z-1378-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
1787 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100052, 9/16/2018 84369, 6/20/2017 84721, 6/26/2017 84951, 6/21/2017 85377, 7/26/2017 86594, 10/8/2017 86595, 10/11/2017 87312, 10/24/2017 87990, 10/6/2017 88277, 10/26/2017 88668, 11/1/2017 89203, 12/16/2017 89605, 12/17/2017 94907, 12/28/2017 94968, 12/5/2017 95303, 2/27/2018 95476, 2/20/2018 96326, 2/1/2018 96619, 2/10/2018 96788, 2/1/2018 96950, 1/5/2018 97302, 3/20/2018 97596, 4/28/2018 97819, 3/15/2018 98048, 3/24/2018 98529, 5/30/2018 98710, 6/10/2018 98945, 5/24/2018 98946, 6/7/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 122 of 124

Upper Torso Tray, part number PSS1554(B

Z-1379-2017
Recall number
Z-1379-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
222 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 100669, 7/6/2019 83865, 5/24/2018 85348, 7/3/2018 87940, 8/12/2018 88676, 8/12/2018 89622, 9/4/2018 95648, 12/5/2018 96352, 2/8/2019 98061, 4/18/2019 98969, 6/18/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 123 of 124

Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A

Z-1380-2017
Recall number
Z-1380-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
360 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 89251, 12/25/2018 89524, 10/25/2018 89601, 12/17/2018 89838, 12/17/2018 99349, 6/18/2019 99729, 10/7/2019

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

device · product 124 of 124

Vein Tray, part number AMS6312

Z-1381-2017
Recall number
Z-1381-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
60 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information

Lot number and expiration date 101265, 11/1/2018

Distribution pattern

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

Field note

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