FDA-Device2012-10-24Class II
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.
Teleflex Medical
Hazard
Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.
Sold states
Nationwide Distribution including the state of Nevada.
Affected count
126 units
Manufactured in
2917 Weck Dr., N/A, Research Triangle Park, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0078-2013Don't want to check this manually?
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