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U.S. Department of Health and Human Services

Enforcement Report - Week of October 24, 2012

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Product Detail

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.
Recall Number Z-0078-2013
Classification Class II
Code Info Catalog No. 544240, Lot #01E1200585
Product Distributed Qty 126 units
Reason For Recall Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.

Event Detail

Event Id 63365
Product Type Devices
Status Ongoing
Recalling Firm Teleflex Medical
City Research Triangle Park
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including the state of Nevada.