Device Recall Bard

Catalog numbers: 0165I108 and 065SI10; All lot numbers produced with IFU (PK7634040) are affected.

Gastroenterology-Urology Devices

2

No

Distributed US (nationwide) and the countries of Canada and Australia.

BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

Code(s): Catalog numbers: 01655SI12, 01655SI14, 01655SI16, 01655SI18, 01655SI20, 01655SI22, 01655SI24, 01655SI26, 01655SI28 and 01655SI30. All lot numbers produced with IFU (PK7634040) are affected.

Gastroenterology-Urology Devices

2

No

Distributed US (nationwide) and the countries of Canada and Australia.

BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

CodeCatalog numbers: 0146SI16, 0146SI18, 0146SI20 and 0146SI22. All lot numbers produced with IFU (PK7634040) are affected.

Gastroenterology-Urology Devices

2

No

Distributed US (nationwide) and the countries of Canada and Australia.

BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

Product Code: DL950J Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699  Product Code: DL950F Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699

Cardiovascular Devices

2

Yes

Distributed to CA only.

Denali Filter-Jugular/Subclavian DL950J || Denali Filter-Femoral Delivery DL950F. || Intravascular filters.

Lot Number NGZE1190

General Hospital and Personal Use Devices

1

No

US Nationwide Distribution - in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, WA, WV, and Puerto Rico

REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. || Product Usage: || Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.