Device product
Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..
Z-1626-2016
Product summary
- Event
- Event 73835
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-1626-2016
Official wording
Reason: Device packaging may not be sealed.
Code information: Lot #481938U
Distribution pattern: US distribution to KY.
Derived failure modes
-
Unknown
Device packaging may not be sealed.