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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83239

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

Open FDA event record

Event summary

Timeline bucket
June 19, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Andover Healthcare 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

6 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 6

Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.

Z-0179-2020
Recall number
Z-0179-2020
Initiated
June 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
Andover Healthcare Inc.
Quantity
1798 Cases

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Incomplete packaging

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete packaging seal of sterile product

Code information

Manufacturer's product or Catalog # 5300S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0ST7, CI0ZJT, CI17BA, CI18Y6, CI1HM0

Distribution pattern

US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA

device · product 2 of 6

Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap

Z-0180-2020
Recall number
Z-0180-2020
Initiated
June 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
Andover Healthcare Inc.
Quantity
8500 Cases

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Incomplete packaging

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete packaging seal of sterile product

Code information

Manufacturer's product or Catalog # 5400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0PVV, CI0V78, CI0X0B, CI16CG, CI17BB, CI18KB, CI18Y7, CI1E36, CI1JCE

Distribution pattern

US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA

device · product 3 of 6

Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap

Z-0181-2020
Recall number
Z-0181-2020
Initiated
June 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
Andover Healthcare Inc.
Quantity
330 Cases

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Incomplete packaging

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete packaging seal of sterile product

Code information

Manufacturer's product or Catalog # 9300S Expiration Date: 01OCT2021-14JUN2022 LOT # CIOZJV, CI02SW, CI18YA, CI1FJ2

Distribution pattern

US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA

device · product 4 of 6

Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap

Z-0182-2020
Recall number
Z-0182-2020
Initiated
June 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
Andover Healthcare Inc.
Quantity
1759 Cases

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Incomplete packaging

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete packaging seal of sterile product

Code information

Manufacturer's product or Catalog # 9400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI147V, CI15F1, CI17B9, CI18Y0, CI1FJ3, CI1JCF

Distribution pattern

US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA

device · product 5 of 6

Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap

Z-0183-2020
Recall number
Z-0183-2020
Initiated
June 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
Andover Healthcare Inc.
Quantity
269 Cases

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Incomplete packaging

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete packaging seal of sterile product

Code information

Manufacturer's product or Catalog # 7300S Expiration Date: 01OCT2021-14JUN2022 Lot : CI10LN

Distribution pattern

US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA

device · product 6 of 6

Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap

Z-0184-2020
Recall number
Z-0184-2020
Initiated
June 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
Andover Healthcare Inc.
Quantity
1050 Cases

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Incomplete packaging

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete packaging seal of sterile product

Code information

Manufacturer's product or Catalog # 7400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0X0D, CI18K8, CI1DXN

Distribution pattern

US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA

Field note

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