LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 55cm Tape 20 strips Catalog Number: 1108-20 Intended to be placed on th
FDA device recall Z-0436-2011 · posted 2010-11-22 · Terminated
Recall details
- Recalling firm
- Lemaitre Vascular, Inc.
- Reason for recall
- Box label (Top Part). Lot and Expiration Date information were switched.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- FTY
- Quantity affected
- 580 units
- Distribution
- Nationwide Distribution -- AL, CA, CT, IL, ME, MI, MS, NC, NJ, NY, PA, PR, TX, and WA.
- Date initiated
- 2010-10-22
- Date posted
- 2010-11-22
- Date terminated
- 2011-09-15
- Location
- Burlington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERILE LEMAITRE GLOW 'N TELL TAPE (K932184) | Vascutech, Inc. | 1993-07-22 |