Device product
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.
Z-0078-2013
Product summary
- Firm
- Teleflex Medical
- Event
- Event 63365
- Status
- Terminated
- Classification
- Class II
- Quantity
- 126 units
- Official record key
device-enforcement:Z-0078-2013
Official wording
Reason: Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.
Code information: Catalog No. 544240, Lot #01E1200585
Distribution pattern: Nationwide Distribution including the state of Nevada.
Derived failure modes
-
Unknown
Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.