Recall Z-0434-2011 ยท FTY Tape, Measuring, Rulers And Calipers
Lemaitre Vascular, Inc.
LeMaitre 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 serving as an internal frame of reference.
| Date | Nov 22, 2010 (initiated Oct 22, 2010) |
| Status | Terminated |
| 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 discard |
| Quantity | 200 units |
| Distribution | Nationwide Distribution -- AL, CA, CT, IL, ME, MI, MS, NC, NJ, NY, PA, PR, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932184 | STERILE LEMAITRE GLOW 'N TELL TAPE Vascutech, Inc., Jul 22, 1993 |