LeMaitre Vascular, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1055-2013)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2013.
Data Source: FDA.
Product Description:
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.
Product Classification:
Class II
Date Initiated: March 18, 2013
Date Posted: April 10, 2013
Recall Number: Z-1055-2013
Event ID: 64704
Reason for Recall:
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
Status: Terminated
Product Quantity: 13560
Code Information:
SGL1190, exp 2017-02; SGL1196, exp 2017-09; SGL1197, exp. 2017-09
Distribution Pattern:
Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
Voluntary or Mandated:
Voluntary: Firm initiated