FDA Enforcement
Class II
Terminated
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: Z-0078-2013
·
Reported October 24, 2012
Enforcement
- Recall Number
- Z-0078-2013
- Event ID
- 63365
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Teleflex Medical
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 24, 2012
- Initiation Date
- September 25, 2012
- Classification Date
- October 18, 2012
- Termination Date
- November 8, 2012
- Address
- 2917 Weck Dr., N/A, Research Triangle Park, NC, 27709, United States
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.
Reason
Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.
Code Info
Catalog No. 544240, Lot #01E1200585
Distribution
Nationwide Distribution including the state of Nevada.
Quantity
126 units