Z-0010-2013 Class II Terminated
FDA device recall Z-0010-2013 was initiated by C.R. Bard, Inc., Urological Division on September 7, 2012 and is designated Class II. 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. The recall status is terminated (terminated March 21, 2013). Affected quantity: 4,032 units.
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