Recall Z-1556-2014 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Teleflex Medical
Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Silky II Polydek White Braided PTFE, Impreg
| Date | May 7, 2014 (initiated Mar 11, 2014) |
| Status | Terminated |
| Reason | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. |
| Root cause | Employee error |
| Action | Urgent Medical Device Recall Notification letters were issued on March 11, 2014 to consignees. The letter requested that customers discontinue use and quarantine any product on hand. The attached Recall Acknowledgment Form should be completed and returned to Teleflex regardless of whether affected product is on hand or not. Once received a customer service representative will contact customers with instructions on how to return the affected product. Questions should be directed to Customer Service at 1-866-246-6990. |
| Quantity | 32,271 ea. |
| Distribution | Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland. |
| 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 |