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 Initiated
- September 7, 2012
- Posted
- October 4, 2012
- Terminated
- March 21, 2013
- Recall Number
- Z-0010-2013
- Quantity
- 4,032 units
- Firm Location
- Covington, GA
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
Nationwide distribution: USA and Puerto Rico
Lot / Code Info
Catalog # 165808, Lot # NGWA1111
Root Cause
Employee error
Action Taken
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.
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