Recalls / —

—#191126

Product

BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C

FDA product code

KOD — Catheter, Urological

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K000723

Affected lot / code info

Serial Number/UDI NGEWX117 (01)00801741183249(17) NGEXX133/(01)00801741183249(17) NGEY0842/(01)00801741183249(17) NGEZ1823/(01)00801741183249(17)

Why it was recalled

There is a potential to leak from the catheter where it connects to the drain bag

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm initiated the recall on 01/27/2022 by letter. The letter explained the issue and the hazard and requested consignee destroy any product on hand. Distributors were directed to destroy all product on hand and to notify their customers of the recall.

Recalling firm

Firm

C.R. Bard Inc

Address

8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

Distribution pattern

US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.

Timeline

Recall initiated

2022-01-27

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #191126. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.