FDA Recall
Terminated
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.
Recall: Z-0010-2013
·
Initiated September 7, 2012
Recall
- Recall Number
- Z-0010-2013
- Event Number
- 63136
- Firm
- C.R. Bard, Inc., Urological Division
- FEI Number
- 1018233
- Product Code
- KOD
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- September 7, 2012
- Posted
- October 4, 2012
- Terminated
- March 21, 2013
- Address
- 8195 Industrial Blvd Ne, Covington, GA, 30014-1497
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
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.
Action
An "Urgent: Product Recall Notification" was sent to all customers and distributors in September 2012 via Federal Express. The letter described the product issue and provided recommended actions. Customers can contact Bard at (770) 784-6471 if questions.
Distribution
Nationwide distribution: USA and Puerto Rico
Quantity
4,032 units