Recall Z-0677-06 ยท MGB Device, Hemostasis, Vascular
St. Jude Medical / Daig Division
Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc., Minnetonka, MN 55345-2126, USA.
| Date | Mar 25, 2006 (initiated Aug 22, 2005) |
| Status | Terminated |
| Reason | Mispackaging-Some Angio-Seal 6F STS Vascular Closure Devices from Lot no. 1146548 have been incorrectly packaged with a 0.035' guidewire instead of a 0.032' guidewire. |
| Root cause | Other |
| Action | Letters were delivered to the hospitals and/or doctors in possession of the product instructing them to return it. |
| Quantity | 4160 |
| Distribution | International Only-Belgium, China, Guadalajara, New Zealand and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.