LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 55cm Tape… recallZ-0436-2011 · Lemaitre Vascular, Inc. · initiated Oct 22, 2010
Terminated All recalls posted in November 2010
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
Box label (Top Part). Lot and Expiration Date information were switched.
FDA root cause category: Labeling Change Control
What the company is doing
Lemaitre Vascular notified customers by an Urgent: VascuTape Radiopaque Tape Device Field Safety Notice letter on 10/22/10 via USPS with delivery confirmation. The Notice advised users of the incorrect lot and lot number on the outer box and also provided an image of the box and label for ease in identifying the product in their inventory. The letter states that the use and functionality of the device are not affected by the problem; however, if customers feel uncomfortable continuing to use the affected device, they can contact Customer Service for replacement. The firm recommended discarding the outer box of the affected product. The letter contains a form that is requested to be returned to LeMaitre Vascular as record of notification and reconciliation. Accounts can contact customer service at 800-628-9470.
Recall details
- Recall number
- Z-0436-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 22, 2010
- Posted by the FDA
- Nov 22, 2010
- Recalling firm
- Lemaitre Vascular, Inc.
- Quantity
- 580 units
- Product code
- FTY
- FDA submissions
- K932184
- Distribution
- Nationwide Distribution -- AL, CA, CT, IL, ME, MI, MS, NC, NJ, NY, PA, PR, TX, and WA.
Product description
LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 55cm Tape 20 strips Catalog Number: 1108-20 Intended to be placed on the patient's skin to assist during imaging procedures by serving as an internal frame of reference.
Code information (models, lots, serial numbers)
Lot Number Exp Date GTFI024 2015-06; GTFI027 2015-07
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 57028).
- Z-0433-2011 · TerminatedLeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 20 strips Catalog Number: 1102-20 Intended to be placed on the patient's skin to assist during imaging procedures by serv…
- Z-0434-2011 · TerminatedLeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 100 strips Catalog Number: 1102-00 Intended to be placed on the patient's skin to assist during imaging procedures by ser…
- Z-0435-2011 · TerminatedLeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 30cm Tape, 100 strips Catalog Number: 1100-00 Intended to be placed on the patient's skin to assist during imaging procedures by s…
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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