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 can be effectively ligated with Hem-o-lok clips.
Recall
- Recall Number
- Z-0078-2013
- Event Number
- 63365
- Firm
- Teleflex Medical
- FEI Number
- 3005747797
- Product Code
- FZP
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- September 25, 2012
- Posted
- October 18, 2012
- Terminated
- November 8, 2012
- Address
- 2917 Weck Dr., Research Triangle Park, NC, 27709
Description
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 can be effectively ligated with Hem-o-lok clips.
Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.
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 action may cause your operations. If you have any questions please contact your local sales representative or Customer Service at 1-866-246-6990.
Nationwide Distribution including the state of Nevada.
126 units