PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: October 24, 2012 Initiated: September 25, 2012 #Z-0078-2013

Product 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.

Reason for Recall

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

Details

Recalling Firm
Teleflex Medical
Units Affected
126 units
Distribution
Nationwide Distribution including the state of Nevada.
Location
Research Triangle Park, NC

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Teleflex Medical. Units affected: 126 units.
Why was this product recalled? ▼
Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 24, 2012. Severity: Moderate. Recall number: Z-0078-2013.

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