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.
Recall
- Recall Number
- Z-0436-2011
- Event Number
- 57028
- Firm
- Lemaitre Vascular, Inc.
- FEI Number
- 1220948
- Product Code
- FTY
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- October 22, 2010
- Posted
- November 22, 2010
- Terminated
- September 15, 2011
- Address
- 63 2nd Ave, Burlington, MA, 01803-4413
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.
Box label (Top Part). Lot and Expiration Date information were switched.
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.
Nationwide Distribution -- AL, CA, CT, IL, ME, MI, MS, NC, NJ, NY, PA, PR, TX, and WA.
580 units