LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin
FDA device recall Z-1054-2013 · posted 2013-04-04 · Terminated
Recall details
- Recalling firm
- LeMaitre Vascular, Inc.
- Reason for recall
- Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
- Action taken
- LeMaitre sent an "URGENT:VASCUTAPE RADIOPAQUE TAPE DEVICE FIELD SAFETY NOTICE" dated March 20, 2013 to affected customers. The recall letter contains a form that requests customers to return to LeMaitre Vascular, Inc. as a record of notification and reconciliation. The letter provides instructions on how the customer can inspect the defective tape seals and/or return the affected products for replacement/credit.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- KFX
- Quantity affected
- 6970
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
- Date initiated
- 2013-03-18
- Date posted
- 2013-04-04
- Date terminated
- 2014-12-03
- 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 |