FDA-Device2013-04-10Class II
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.
LeMaitre Vascular, Inc.
Hazard
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
Affected count
6970
Manufactured in
63 2nd Ave, N/A, Burlington, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1054-2013Don't want to check this manually?
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