Glow 'N Tell 20 cm Tape: 1100-00 (100 strips) recallZ-1055-2013 · LeMaitre Vascular, Inc. · initiated Mar 18, 2013
Class II Terminated All recalls posted in April 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from LeMaitre Vascular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
FDA root cause category: Packaging process control
What the company is doing
LeMaitre sent an "URGENT:VASCUTAPE RADIOPAQUE TAPE DEVICE FIELD SAFETY NOTICE" dated March 20, 2013 to affected customers. The recall letter contains a form that requests customers to return to LeMaitre Vascular, Inc. as a record of notification and reconciliation. The letter provides instructions on how the customer can inspect the defective tape seals and/or return the affected products for replacement/credit.
Recall details
- Recall number
- Z-1055-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 18, 2013
- Posted by the FDA
- Apr 4, 2013
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 13560
- Product code
- KFX
- FDA submissions
- K932184
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
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.
Code information (models, lots, serial numbers)
SGL1190, exp 2017-02; SGL1196, exp 2017-09; SGL1197, exp. 2017-09
Other devices under the same FDA submission
1 device cleared under K932184 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- VascuTape Radiopaque Tape 1108-20Lemaitre Vascular, Inc. · Assembly, Thigh/Knee/Shank/Ankle/Foot, External1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 64704).
- Z-1054-2013 · TerminatedLeMaitre 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.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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