Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
FDA device recall Z-0198-2016 · posted 2015-11-02 · Terminated
Recall details
- Recalling firm
- C.R. Bard, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MJC
- Quantity affected
- 4,170 each
- Distribution
- Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA.
- Date initiated
- 2015-10-02
- Date posted
- 2015-11-02
- Date terminated
- 2016-08-01
- 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 |
|---|---|---|
| HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT (K033477) | Rochester Medical Corp. | 2004-06-10 |