Enforcement Report - Week of October 24, 2012
-
Back to Previous Page
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 |
-
