Device product
LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252
Z-1294-2015
Product summary
- Event
- Event 70698
- Status
- Terminated
- Classification
- Class III
- Quantity
- 54 units
- Official record key
device-enforcement:Z-1294-2015
Official wording
Reason: Mislabeled with an incorrect expiration date
Code information: Lot Number: 61049252 Exp. Date: 2016-06
Distribution pattern: CA, CO, KS, MN, UT, WA, WI
Derived failure modes
-
Labeling or packaging
Mislabeled