FDAFDA · Food and drugs·Recall number Z-1054-2013
LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
Published April 10, 2013 · Recall initiated: March 18, 2013
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
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- LeMaitre Vascular, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
- Lot
- LSG1130, exp. 2017-04; LSG1132, exp. 2017-11
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.