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. |
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| 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. |
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