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Terminated

8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

FDA Recall Z-0010-2013 · Posted 2012-10-04

Recalling FirmC.R. Bard, Inc., Urological Division
Recall StatusTerminated
Product CodeKOD
Date Initiated2012-09-07
Date Terminated2013-03-21
Product Quantity4,032 units

Reason for Recall

The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap.

Firm Action

An "Urgent: Product Recall Notification" was sent to all customers and distributors in September 2012 via Federal Express. The letter described the product issue and provided recommended actions. Customers can contact Bard at (770) 784-6471 if questions.

Root Cause

Employee error

Distribution Pattern

Nationwide distribution: USA and Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K821745BARDEX ALL SILICONE PEDIATRIC CATHETERC.R. Bard, Inc. · 1982-06-24

Official Source

View FDA Recall →

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

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