FDAFDA · Food and drugs·Recall number Z-0078-2013
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.
Published October 24, 2012 · Recall initiated: September 25, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- Nationwide Distribution including the state of Nevada.
- Lot
- Catalog No. 544240, Lot #01E1200585
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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