—#113590

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.

FDA product code: FZP — Clip, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K993157
Affected lot / code info: Catalog No. 544240, Lot #01E1200585

Why it was recalled

Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr., Research Triangle Park, North Carolina 27709

Distribution

Distribution pattern: Nationwide Distribution including the state of Nevada.

Timeline

Recall initiated: 2012-09-25
Posted by FDA: 2012-10-18
Terminated: 2012-11-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #113590. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.