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LeMaitre Vascular, Inc. recalls LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the sk
Recalled April 10, 2013 · FDA recall Z-1054-2013 · LeMaitre Vascular
Hazard
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised. · FDA Class II
Units
6970
Sold at
Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
Description
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
Product
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.
Manufacturer(s)
LeMaitre Vascular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →