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 Insight

This FDA Devices action (record #Z-0078-2013) was formally reported on October 24, 2012, with the manufacturer initiating the action on September 25, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Teleflex Medical is listed as the recalling firm, operating out of Research Triangle Park, NC. Federal records list the affected scope as 126 units.

The documented reason for this recall is: Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility. Distribution data in the federal record shows the product reached: Nationwide Distribution including the state of Nevada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.