8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 unit
FDA device recall Z-0010-2013 · posted 2012-10-04 · Terminated
Recall details
- Recalling firm
- C.R. Bard, Inc., Urological Division
- 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.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- KOD
- Quantity affected
- 4,032 units
- Distribution
- Nationwide distribution: USA and Puerto Rico
- Date initiated
- 2012-09-07
- Date posted
- 2012-10-04
- Date terminated
- 2013-03-21
- Location
- Covington, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARDEX ALL SILICONE PEDIATRIC CATHETER (K821745) | C.R. Bard, Inc. | 1982-06-24 |