Z-0436-2011

LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 55cm Tape 20 strips Catalog Number: 1108-20 Intended to be...

Name: Z-0436-2011 LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 55cm Tape 20 strips Catalog Number: 1108-20 Intended to be...
Creator: Lemaitre Vascular, Inc.
Published: 2010-10-22
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2010-10-22 / Terminated / root cause: labeling and UDI

FDA source

Lemaitre Vascular, Inc. began a recall of 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... on 2010-10-22. The reason FDA records is "Box label (Top Part). Lot and Expiration Date information were switched". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0436-2011
Status: Terminated
Initiated: 2010-10-22
Posted: 2010-11-22
Terminated: 2011-09-15
Recalling firm: LeMaitre Vascular Inc.
Product: 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.
Product code: FTY Tape, Measuring, Rulers And Calipers
Reason for recall: Box label (Top Part). Lot and Expiration Date information were switched.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 580 units
Distribution: Nationwide Distribution -- AL, CA, CT, IL, ME, MI, MS, NC, NJ, NY, PA, PR, TX, and WA.
Product codes and lots: Lot Number Exp Date GTFI024 2015-06; GTFI027 2015-07

Product code FTY

K932184Class IISterile Lemaitre Glow 'N Tell TapeVascutech, Inc. / cleared 1993-07-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)