FDA Medical Device Recalls (openFDA)
Lemaitre Vascular, Inc.: LeMaitre 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 serving as an internal frame of reference.
- Recall number
- Z-0435-2011
- Recalling firm
- Lemaitre Vascular, Inc.
- Product
- LeMaitre 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 serving as an internal frame of reference.
- Status
- Terminated
- Initiated
- 2010-10-22
- Posted
- 2010-11-22
- Terminated
- 2011-09-15
- Reason
- Box label (Top Part). Lot and Expiration Date information were switched.
- 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
- 1000 units
- Distribution
- Nationwide Distribution -- AL, CA, CT, IL, ME, MI, MS, NC, NJ, NY, PA, PR, TX, and WA.
- Lot, serial or model codes
- Lot Number: SGL1164 Exp. Date: 2015-07
- 510(k) numbers
- ["K932184"]
- PMA numbers
- not on file
- Product code
- FTY
- Firm FEI
- 1220948
- Firm city
- Burlington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28