Recall Z-0010-2013— C.R. Bard, Inc., Urological Division

Name: FDA recall Z-0010-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-07

Class II · Terminated

Class II FDA medical device recall by C.R. Bard, Inc., Urological Division, initiated 2012-09-07, terminated 2013-03-21. It names one FDA 510(k) clearance: K821745. Product: 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: 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..

Recalling firm: C.R. Bard, Inc., Urological Division
Classification: Class II
Status: Terminated
Initiated: 2012-09-07
Terminated: 2013-03-21
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K821745 — BARDEX ALL SILICONE PEDIATRIC CATHETERC.R. Bard, Inc.·cleared 1982-06-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.