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Terminated

BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C

FDA Recall Z-0667-2022 · Posted None

Recalling FirmC.R. Bard Inc
Recall StatusTerminated
Product CodeKOD
Date Initiated2022-01-27
Date Terminated2026-07-10
Product Quantity1620 units

Reason for Recall

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

Firm Action

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.

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000723HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)Rochester Medical Corp. · 2000-05-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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