Recall Z-0198-2016 ยท MJC Catheter, Urological (Antimicrobial) And Accessories
C.R. Bard, Inc.
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
| Date | Nov 2, 2015 (initiated Oct 2, 2015) |
| Status | Terminated |
| Reason | Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French. |
| Root cause | Error in labeling |
| Action | Bard sent a Customer Notification Letter dated September 29 to customers via FedEx with proof of delivery notice. The letter identified the product, the problem, and the action to be taken by the customer. The consignees were instructed to carry out the notification to the user level. Customers with questions were instructed to contact BMD at 1-770-784-6471. |
| Quantity | 4,170 each |
| Distribution | Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033477 | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT Rochester Medical Corp., Jun 10, 2004 |