Home / Recalls / C.R. Bard, Inc., Urological Division / Z-0010-2013

Z-0010-2013 Class II Terminated

Recalled by C.R. Bard, Inc., Urological Division — Covington, GA

Recall Details

Product Type: Devices
Report Date: October 10, 2012
Initiation Date: September 7, 2012
Termination Date: March 21, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,032 units

Product Description

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.

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.

Distribution Pattern

Nationwide distribution: USA and Puerto Rico

Code Information

Catalog # 165808, Lot # NGWA1111