Recall Z-0663-03 ยท DQO Catheter, Intravascular, Diagnostic
Curon Medical Inc
Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K
| Date | Mar 20, 2003 (initiated Feb 21, 2003) |
| Status | Terminated |
| Reason | Catheter shaft has potential to crack during use. |
| Root cause | Other |
| Action | On 2/21/03 the firm initiated the recall and its notification was via letters to inform its consignees about the problem with its catheters. It requests immediate discontinuance of all product with certain lot numbers. |
| Distribution | Product was released for distribution to 52 direct accounts nationwide including 1 VA Medical Center, Endoscopy Dept., 150 S. Huntington Ave., Boston, MA 02130, ATTN: Dr. Hiroshi Mashimo, ph#: 617-363-5640. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.