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U.S. Department of Health and Human Services

Enforcement Report - Week of October 24, 2012

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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.

Product Detail

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