C.R. Bard, Inc., Urological Division recalls 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 uni

Recalled October 10, 2012 · FDA recall Z-0010-2013 · C.R. Bard, Inc., Urological Division

Hazard

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. · FDA Class II

Units

4,032 units

Sold at

Nationwide distribution: USA and Puerto Rico

Description

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.

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.

Manufacturer(s)

C.R. Bard, Inc., Urological Division

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →