Recall Z-0085-06 ยท GAR Suture, Nonabsorbable, Synthetic, Polyamide
Surgical Specialties Corp
Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model number 933B. The product is shipped in boxes containing 12 units.
| Date | Oct 21, 2005 (initiated Sep 24, 2005) |
| Status | Terminated |
| Reason | mislabeled as double armed straight needle actually single armed straight needle |
| Root cause | Other |
| Action | On 9/24/05, the recalling firm issued notifications to their customers via fax informing them of the problem and the need to return any remaining product to the recalling firm. |
| Quantity | 27 boxes |
| Distribution | The product was shipped to hospitals in IL, KY, NC, NE, OR, UT, and VA. The product was also shipped to distributors in FL, KY, PA, TN, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.