Recall Z-1291-2014 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Teleflex Medical
Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation.
| Date | Mar 26, 2014 (initiated Mar 11, 2014) |
| Status | Terminated |
| Reason | The products are being recalled because they did not meet minimum needle attachment strength requirements. |
| Root cause | Employee error |
| Action | Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990 |
| Quantity | Total 32,271 ea. |
| Distribution | Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021019 | COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE Genzyme Corp., Jun 18, 2002 |