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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86433

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

Open FDA event record

Event summary

Timeline bucket
August 31, 2020
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Vascular Solutions, 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

4 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 4

Langston Dual Lumen Catheter

Z-0110-2021
Recall number
Z-0110-2021
Initiated
August 31, 2020
Classification
Class I
Status
Terminated
Recalling firm
Vascular Solutions, Inc.
Quantity
1,680 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The inner lumen of the Langston catheter may separate from the hub during pressure injection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The inner lumen of the Langston catheter may separate from the hub during pressure injection.

Code information

Model Number: 5515, UDI 10841156100506 Lot Numbers: 635806, 640206, 644140, 648701, 654143, 658252, 659635, 661470, 665301, 670376, 654130, 672728, 656020, 638111, 677058.

Distribution pattern

Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL ,GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,NM ,NV ,NY ,OH ,OK,OR, PA ,PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. International Distribution: Austria, Australia, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Oman, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom.

device · product 2 of 4

Langston Dual Lumen Catheter.

Z-0111-2021
Recall number
Z-0111-2021
Initiated
August 31, 2020
Classification
Class I
Status
Terminated
Recalling firm
Vascular Solutions, Inc.
Quantity
89,121 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The inner lumen of the Langston catheter may separate from the hub during pressure injection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The inner lumen of the Langston catheter may separate from the hub during pressure injection.

Code information

Model Number: 5540, UDI, 10841156100513, Lots 643376, 633647, 639516, 645032, 649315, 650991, 656191, 658151, 659443, 660590, 666438, 670586, 672660, 635207, 636898, 643051, 644573, 645360, 645482, 648481, 649729, 650018, 650873, 651457, 653053, 655645, 655738, 657627, 658250, 658824, 659122, 659217, 660910, 661139, 663039, 663344, 665098, 665099, 666559, 668703, 671743, 671948, 672894, 633211, 635208, 635542, 636901, 637832, 644015, 646106, 649078, 650765, 654190, 657517, 657680, 660717, 662903, 663138, 665303, 667164, 669190, 647786, 671427, 634423, 634247, 648043, 648963, 651920, 653863, 660823, 662493, 661257, 650369, 638953, 669199, 658438, 668701, 636284, 640938, 641222, 641543, 641679, 642031, 650023, 654010, 655128, 657030, 660075, 663281, 663790, 663854, 635805, 659362, 668303, 666966, 632018, 635209, 643835, 645118, 646247, 647482, 649456, 652176, 653319, 656554, 659630, 661863, 662824, 665234, 669602, 647370, 648337, 672813, 664087, 657243, 652097, 668095, 636471, 640676, 642373, 642520, 644650, 654890, 655460, 657866, 658018, 661474, 662053, 662133, 664449, 667465, 668934, 670503, 672130, 663791, 635280, 669402, 632020, 638198, 639892, 640034, 648603, 653565, 654889, 658984, 662642, 671202, 643542, 645481, 672349, 635541, 661707, 666332, 670144, 654514, 654657, 671004, 671633,637388,645031, 646641, 650606, 670299, 642928, 670865, 639414, 642178, 646110, 651524, 660199, 668094, 669591, 641060, 647014, 651163, 655869, 656727 ,647697, 635861, 640459, 666067, 667936, 632019, 638323, 643874, 646108, 648210, 649584, 654340, 658541, 664236, 633929, 646640, 653443, 668305, 668771, 655287, 662265, 637384, 651829, 669737, 648780, 652777, 653776, 658671, 667832, 637945, 651278, 652628, 660288, 667151, 656801, 646879, 650560, 652459, 659855, 660397, 667835, 636709, 647206, 673021, 649315.

Distribution pattern

Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL ,GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,NM ,NV ,NY ,OH ,OK,OR, PA ,PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. International Distribution: Austria, Australia, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Oman, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom.

device · product 3 of 4

Langston Dual Lumen Catheter.

Z-0112-2021
Recall number
Z-0112-2021
Initiated
August 31, 2020
Classification
Class I
Status
Terminated
Recalling firm
Vascular Solutions, Inc.
Quantity
1,745 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The inner lumen of the Langston catheter may separate from the hub during pressure injection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The inner lumen of the Langston catheter may separate from the hub during pressure injection.

Code information

Model Number: 5545, UDI 10841156100520 total 1745, Lots: 634357, 645111, 649740, 650126, 655647, 657411, 661790, 666866, 673313, 638819, 650127, 659802, 672219, 675001, 638547, 668503.

Distribution pattern

Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL ,GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,NM ,NV ,NY ,OH ,OK,OR, PA ,PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. International Distribution: Austria, Australia, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Oman, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom.

device · product 4 of 4

Langston Dual Lumen Catheter.

Z-0113-2021
Recall number
Z-0113-2021
Initiated
August 31, 2020
Classification
Class I
Status
Terminated
Recalling firm
Vascular Solutions, Inc.
Quantity
2990 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The inner lumen of the Langston catheter may separate from the hub during pressure injection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The inner lumen of the Langston catheter may separate from the hub during pressure injection.

Code information

Model Number: 5550, UDI 10841156100537 total 2990, Lots: 637973, 640204, 659555, 660597, 633668, 663767, 669593, 659856, 644096, 676528, 672481, 632704, 656792, 658273, 666755, 635885.

Distribution pattern

Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL ,GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,NM ,NV ,NY ,OH ,OK,OR, PA ,PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. International Distribution: Austria, Australia, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Oman, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom.

Field note

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