Recall Z-1017-2007 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Teleflex Creek Dr
Various Types and Sizes of Polyethylene Synthetic Nonabsorable Sutures-Polyester, TEV GN BR 0 TC-43/HR 262N, Catalog #833-114
| Date | Jul 17, 2007 (initiated Jun 6, 2007) |
| Status | Terminated |
| Reason | Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. |
| Root cause | Other |
| Action | Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical. |
| Quantity | 1920 units total for all types of sutures |
| Distribution | Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001434 | 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE Genzyme Surgical Product (Genzyme Biosurgery), Jun 12, 2000 |
| K001440 | NEXTSTITCH CARDIOVASCULAR VALVE SUTURE Genzyme Surgical Product (Genzyme Biosurgery), Nov 13, 2000 |
| K021019 | COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE Genzyme Corp., Jun 18, 2002 |