Recall Z-0078-2013
Teleflex Medical · initiated September 25, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Catalog No. 544240, Lot #01E1200585
Reason for recall
Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-0078-2013
- Initiated
- September 25, 2012
- Posted by FDA
- October 18, 2012
- Terminated
- November 8, 2012
- Product code
- FZP – Clip, Implantable
- Quantity
- 126 units
- Distribution
- Nationwide Distribution including the state of Nevada.
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC