Recall Z-0002-04 ยท GBR
Bard Peripheral Vascular Inc
Opti-Plast Balloon Dilatation Catheters
| Date | Oct 15, 2003 (initiated Aug 20, 2003) |
| Status | Terminated |
| Reason | Product intended for distribution outside USA was distributed without premarket notification requirements being met. |
| Root cause | Other |
| Action | The firm notified territory managers by telephone on August 20, 2003 to hold all consigned devices for return. |
| Quantity | 14 units |
| Distribution | OH, AL, MS, LA, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.