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LeMaitre Vascular, Inc. recalls Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on th
Recalled April 10, 2013 · FDA recall Z-1055-2013 · 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
13560
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
Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (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 →