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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80169

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

Open FDA event record

Event summary

Timeline bucket
May 10, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Angiodynamics Inc. (Navilyst Medical 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

38 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 38

XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124

Z-2188-2018
Recall number
Z-2188-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
7 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965251240; Lot: 5303187

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 2 of 38

Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818

Z-2189-2018
Recall number
Z-2189-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
50 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965458180; Lot: 5303175, 5305572

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 3 of 38

Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871

Z-2190-2018
Recall number
Z-2190-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
200 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965458710; Lot: 5303177

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 4 of 38

Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872

Z-2191-2018
Recall number
Z-2191-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
20 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965458720; Lot: 5304983

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 5 of 38

Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882

Z-2192-2018
Recall number
Z-2192-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
17 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965458820; Lot: 5301752

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 6 of 38

Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886

Z-2193-2018
Recall number
Z-2193-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
58 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965458860; Lot: 5303442

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 7 of 38

Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887

Z-2194-2018
Recall number
Z-2194-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
246 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965458870; Lot: 5305574

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 8 of 38

Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892

Z-2195-2018
Recall number
Z-2195-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
11 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965458920; Lot: 5304323

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 9 of 38

Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895

Z-2196-2018
Recall number
Z-2196-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
298 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965458950; Lot: 5304321

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 10 of 38

Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901

Z-2197-2018
Recall number
Z-2197-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
86 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965459011; Lot: G18012001, G18064125

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 11 of 38

BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490

Z-2198-2018
Recall number
Z-2198-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
190 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965464901; Lot: 5302405, 5312036, 5314940

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 12 of 38

BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810

Z-2199-2018
Recall number
Z-2199-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
23 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965468100; Lot: 5314926

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 13 of 38

RS TANDEM 5F DL XPP, Catalog Number 60M019881

Z-2200-2018
Recall number
Z-2200-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
7

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M0198811; Lot: 5299857

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 14 of 38

RS 5F DL XPP, Catalog Number 60M030393

Z-2201-2018
Recall number
Z-2201-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
7 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M0303931; Lot: 5304317, 5304317

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 15 of 38

RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472

Z-2202-2018
Recall number
Z-2202-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
3 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M0354721; Lot: 5312194

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 16 of 38

RS 5F DL BIOFLO PICC, Catalog Number 60M071831

Z-2203-2018
Recall number
Z-2203-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
12 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M0718311; Lot: 5310191

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 17 of 38

RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196

Z-2204-2018
Recall number
Z-2204-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
2 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M1201961; Lot: 5314930

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 18 of 38

RS 5F DL BIOFLO PASV, Catalog Number 60M132324

Z-2205-2018
Recall number
Z-2205-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
2 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M1323241; Lot: 5312922

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 19 of 38

TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567

Z-2206-2018
Recall number
Z-2206-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
1 box

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M1405671; Lot: 5316349

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 20 of 38

5F DL BIOFLO PASV, Catalog Number 60M141006

Z-2207-2018
Recall number
Z-2207-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
36 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M1410061; Lot: 5304286, 5318620

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 21 of 38

RS 5F DL BIOFLO PASV, Catalog Number 60M150373

Z-2208-2018
Recall number
Z-2208-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
7 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M1503731; Lot: 5303174

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 22 of 38

RS 5F DL BIOFLO PASV, Catalog Number 60M161567

Z-2209-2018
Recall number
Z-2209-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
2 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M1615671; Lot: 5316086

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 23 of 38

5F DL BIOFLO PICC, Catalog Number 60M180592

Z-2210-2018
Recall number
Z-2210-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
12 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M1805921; Lot: 5313507, 5316369, 5318603, 5321025

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 24 of 38

RS 5F DL BIOFLO PASV, Catalog Number 60M181578

Z-2211-2018
Recall number
Z-2211-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
11 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M1815781; Lot: 5303172, 5310562

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 25 of 38

RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582

Z-2212-2018
Recall number
Z-2212-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
13 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M1815821; Lot: 5299859

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 26 of 38

RS 5F DL XPP KIT, Catalog Number 60M183104

Z-2213-2018
Recall number
Z-2213-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
5 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M1831041; Lot: 5310755

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 27 of 38

RS 5F DL BIOFLO PASV, Catalog Number 60M183481

Z-2214-2018
Recall number
Z-2214-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
104 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M1834811; Lot: 5301023, 5310193, 5312020

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 28 of 38

RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242

Z-2215-2018
Recall number
Z-2215-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
20 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M2322421; Lot: 5304324, 5316020

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 29 of 38

RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097

Z-2216-2018
Recall number
Z-2216-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
15 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M2500971; Lot: 5303198, 5320749

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 30 of 38

CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936

Z-2217-2018
Recall number
Z-2217-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
2 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M7009361; Lot: 5316398,

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 31 of 38

CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531

Z-2218-2018
Recall number
Z-2218-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
17 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M7015311; Lot: 5299826, 5312185

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 32 of 38

CAN 5F DUAL XCELA PICC, Catalog Number 60M701532

Z-2219-2018
Recall number
Z-2219-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
27 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H96560M7015321; Lot: 5300582, 5312582

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 33 of 38

Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003

Z-2220-2018
Recall number
Z-2220-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
99 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965750031; Lot: 5301074, 5304327, 5308920

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 34 of 38

BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019

Z-2221-2018
Recall number
Z-2221-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
132 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965750191; Lot: 5301073, 5304893

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 35 of 38

BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032

Z-2222-2018
Recall number
Z-2222-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
3 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965750325; Lot: 5312035

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 36 of 38

BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-033

Z-2223-2018
Recall number
Z-2223-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
81 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965750335; Lot: 5310029, 5310762

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 37 of 38

BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038

Z-2224-2018
Recall number
Z-2224-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
79 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: H965750385; Lot: 5301462, 5316413, 5320267

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

device · product 38 of 38

RS 5F DL XCELA PICC, Catalog Number 60M122272

Z-2225-2018
Recall number
Z-2225-2018
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Quantity
6 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information

UPN: M00160M1222721; Lot: 5312021

Distribution pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.