FDA-Device2013-04-10Class II
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.
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
13560
Manufactured in
63 2nd Ave, N/A, Burlington, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1055-2013Don't want to check this manually?
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