C.R. Bard, Inc., Urological Division: Medical Device Recall in 2012 - (Recall #: Z-0010-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 7, 2012

Date Posted: October 10, 2012

Recall Number: Z-0010-2013

Event ID: 63136

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.

Status: Terminated

Product Quantity: 4,032 units

Code Information:

Catalog # 165808, Lot # NGWA1111

Distribution Pattern:

Nationwide distribution: USA and Puerto Rico

Voluntary or Mandated:

Voluntary: Firm initiated