Device 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.
Z-1054-2013
Product summary
- Event
- Event 64704
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6970
- Official record key
device-enforcement:Z-1054-2013
Official wording
Reason: Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
Code information: LSG1130, exp. 2017-04; LSG1132, exp. 2017-11
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
Derived failure modes
-
Unknown
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.