Recall Z-2538-2016 ยท HCF Instrument, Ligature Passing And Knot Tying
Teleflex Medical
Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery
| Date | Mar 24, 2016 |
| Status | Terminated |
| Reason | Incorrect expiration date was printed on the product label. |
| Root cause | Unknown/Undetermined by firm |
| Action | Teleflex sent an Urgent Medical Device Recall Notification letter dated March 24, 2016, to all affected consignees. The letter requested that consignees check their stock, immediately discontinue use and quarantine any products. To return affected product consignees were instructed to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, ATTN: Customer Service or email to recalls@teleflex.com. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990. For questions regarding this recall call 610-378- |
| Quantity | 45 |
| Distribution | Nationwide Distribution to CA, CO, IA, KS, MD, MI, NY, NC, PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.