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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Angiodynamics Inc. (Navilyst Medical Inc.): A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Agency Publication Date: June 14, 2018
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Affected Products

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

UPN: H965251240; Lot: 5303187

Lot Numbers:
5303187
Product: Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818

UPN: H965458180; Lot: 5303175, 5305572

Lot Numbers:
5303175
Product: Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871

UPN: H965458710; Lot: 5303177

Lot Numbers:
5303177
Product: Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872

UPN: H965458720; Lot: 5304983

Lot Numbers:
5304983
Product: Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882

UPN: H965458820; Lot: 5301752

Lot Numbers:
5301752
Product: Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886

UPN: H965458860; Lot: 5303442

Lot Numbers:
5303442
Product: Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887

UPN: H965458870; Lot: 5305574

Lot Numbers:
5305574
Product: Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892

UPN: H965458920; Lot: 5304323

Lot Numbers:
5304323
Product: Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895

UPN: H965458950; Lot: 5304321

Lot Numbers:
5304321
Product: Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901

UPN: H965459011; Lot: G18012001, G18064125

Lot Numbers:
G18012001
Product: BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490

UPN: H965464901; Lot: 5302405, 5312036, 5314940

Lot Numbers:
5302405
Product: BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810

UPN: H965468100; Lot: 5314926

Lot Numbers:
5314926
Product: RS TANDEM 5F DL XPP, Catalog Number 60M019881

UPN: H96560M0198811; Lot: 5299857

Lot Numbers:
5299857
Product: RS 5F DL XPP, Catalog Number 60M030393

UPN: H96560M0303931; Lot: 5304317, 5304317

Lot Numbers:
5304317
Product: RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472

UPN: H96560M0354721; Lot: 5312194

Lot Numbers:
5312194
Product: RS 5F DL BIOFLO PICC, Catalog Number 60M071831

UPN: H96560M0718311; Lot: 5310191

Lot Numbers:
5310191
Product: RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196

UPN: H96560M1201961; Lot: 5314930

Lot Numbers:
5314930
Product: RS 5F DL BIOFLO PASV, Catalog Number 60M132324

UPN: H96560M1323241; Lot: 5312922

Lot Numbers:
5312922
Product: TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567

UPN: H96560M1405671; Lot: 5316349

Lot Numbers:
5316349
Product: 5F DL BIOFLO PASV, Catalog Number 60M141006

UPN: H96560M1410061; Lot: 5304286, 5318620

Lot Numbers:
5304286
Product: RS 5F DL BIOFLO PASV, Catalog Number 60M150373

UPN: H96560M1503731; Lot: 5303174

Lot Numbers:
5303174
Product: RS 5F DL BIOFLO PASV, Catalog Number 60M161567

UPN: H96560M1615671; Lot: 5316086

Lot Numbers:
5316086
Product: 5F DL BIOFLO PICC, Catalog Number 60M180592

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

Lot Numbers:
5313507
Product: RS 5F DL BIOFLO PASV, Catalog Number 60M181578

UPN: H96560M1815781; Lot: 5303172, 5310562

Lot Numbers:
5303172
Product: RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582

UPN: H96560M1815821; Lot: 5299859

Lot Numbers:
5299859
Product: RS 5F DL XPP KIT, Catalog Number 60M183104

UPN: H96560M1831041; Lot: 5310755

Lot Numbers:
5310755
Product: RS 5F DL BIOFLO PASV, Catalog Number 60M183481

UPN: H96560M1834811; Lot: 5301023, 5310193, 5312020

Lot Numbers:
5301023
Product: RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242

UPN: H96560M2322421; Lot: 5304324, 5316020

Lot Numbers:
5304324
Product: RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097

UPN: H96560M2500971; Lot: 5303198, 5320749

Lot Numbers:
5303198
Product: CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936

UPN: H96560M7009361; Lot: 5316398,

Lot Numbers:
5316398
Product: CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531

UPN: H96560M7015311; Lot: 5299826, 5312185

Lot Numbers:
5299826
Product: CAN 5F DUAL XCELA PICC, Catalog Number 60M701532

UPN: H96560M7015321; Lot: 5300582, 5312582

Lot Numbers:
5300582
Product: Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003

UPN: H965750031; Lot: 5301074, 5304327, 5308920

Lot Numbers:
5301074
Product: BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019

UPN: H965750191; Lot: 5301073, 5304893

Lot Numbers:
5301073
Product: BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032

UPN: H965750325; Lot: 5312035

Lot Numbers:
5312035
Product: BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-033

UPN: H965750335; Lot: 5310029, 5310762

Lot Numbers:
5310029
Product: BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038

UPN: H965750385; Lot: 5301462, 5316413, 5320267

Lot Numbers:
5301462
Product: RS 5F DL XCELA PICC, Catalog Number 60M122272

UPN: M00160M1222721; Lot: 5312021

Lot Numbers:
5312021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80169
Status: Resolved
Manufacturer: Angiodynamics Inc. (Navilyst Medical Inc.)
Manufactured In: United States
Units Affected: 38 products (7 boxes; 50 boxes; 200 boxes; 20 boxes; 17 boxes; 58 boxes; 246 boxes; 11 boxes; 298 boxes; 86 boxes; 190 boxes; 23 boxes; 7; 7 boxes; 3 boxes; 12 boxes; 2 boxes; 2 boxes; 1 box; 36 boxes; 7 boxes; 2 boxes; 12 boxes; 11 boxes; 13 boxes; 5 boxes; 104 boxes; 20 boxes; 15 boxes; 2 boxes; 17 boxes; 27 boxes; 99 boxes; 132 boxes; 3 boxes; 81 boxes; 79 boxes; 6 boxes)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.