Recall Z-0157-2007 ยท MGB Device, Hemostasis, Vascular
St. Jude Medical / Daig Division
The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is the 6 French model size.
| Date | Nov 7, 2006 (initiated Jun 7, 2006) |
| Status | Terminated |
| Reason | The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038'' guidewire vs. the required 0.035'' guidewire. |
| Root cause | Other |
| Action | All consignees were notified by letter on June 7, 2006. All product is to be retreived by recalling firm''s sales force for return to St. Jude Medical, in Minnetonka, MN. |
| Quantity | 4,770 Units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.