Recall Z-1054-2013
LeMaitre Vascular, Inc. · initiated March 18, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
Codes / lots: LSG1130, exp. 2017-04; LSG1132, exp. 2017-11
Reason for recall
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
FDA-determined cause: Packaging process control
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.
Details
- Recall number
- Z-1054-2013
- Initiated
- March 18, 2013
- Posted by FDA
- April 4, 2013
- Terminated
- December 3, 2014
- Product code
- KFX – Assembly, Thigh/Knee/Shank/Ankle/Foot, External
- Quantity
- 6970
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
- Recalling firm
- LeMaitre Vascular, Inc., Burlington, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1055-2013 Class II | Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips).…Devices were not sealed correctly during the manufacturing process, and the sterility of these products have… | 03/18/2013Terminated |