Recall Z-0078-2013 ยท FZP Clip, Implantable
Teleflex Medical
Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Medicals Hem-o-lok polymer ligating clips are single use, sterile, non-absorbable medial devices that have been designed to ligate vessels and tissue structures during various types of surgical procedures. Vessels and tissue structures in the range of 0.5 to 16 mm ca
| Date | Oct 18, 2012 (initiated Sep 25, 2012) |
| Status | Terminated |
| Reason | Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility. |
| Root cause | Packaging process control |
| Action | Teleflex sent a Urgent Medical Device Recall Notification dated September 25, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their inventory and quarantine any affected inventory found. They were to complete the enclosed Field Corrective Action Acknowledgement Form and return it to the Teleflex Medical sales representative who will then remove the affected product from the facility and ensure its return to Teleflex Medical. We sincerely apologize for any inconvenience this ac |
| Quantity | 126 units |
| Distribution | Nationwide Distribution including the state of Nevada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993157 | HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240 Weck Closure Systems, Dec 17, 1999 |