Device product
Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
Z-1246-2021
Product summary
- Event
- Event 87284
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 units
- Official record key
device-enforcement:Z-1246-2021
Official wording
Reason: Sterility may be compromised due to an unsealed pouch
Code information: Lot Code: 220754416, 220754417
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
unsealed pouch
-
Sterility assurance
Sterility may be compromised