Recall Z-0260-06 ยท GAD Retractor
Boston Scientific Corporation
Precision Twist Transvaginal Sling Kit with Non-Absorbable, Polybutester Monofilament Suture (contains 1 Product Code 820-175) Product Code: 820-172
| Date | Dec 1, 2005 (initiated Oct 25, 2005) |
| Status | Terminated |
| Reason | Sterility of device compromised due to breach in packaging |
| Root cause | Other |
| Action | Boston Scientific initiated the recall on October 25, 2005 to accouunts requesting the return of the product and completion of the Reply Verification Tracking Form. |
| Quantity | 322 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.