Recall Z-1497-2014 ยท GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Teleflex Medical
Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.
| Date | Apr 24, 2014 (initiated Mar 11, 2014) |
| Status | Terminated |
| Reason | The products are being recalled because they did not meet minimum diameter requirements. |
| Root cause | Other |
| Action | Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected constomers. The letter identified the affected product, problem and actions to be taken. Customers were instructed if they have affected stock immediately discontinue use, quarantine, and return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgement Form and Fax it to 1-508-964-6078, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-508-9 |
| Quantity | 3,816 ea |
| Distribution | Worldwide Distribution - CA, CO, FL, IN, KY, MA, NM, PA, Canada, Ireland and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930738 | SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC Deknatel, Inc., Jul 26, 1994 |