Device product
NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
Z-2822-2018
Product summary
- Firm
- Nico Corp.
- Event
- Event 80540
- Status
- Terminated
- Classification
- Class II
- Quantity
- 204 devices
- Official record key
device-enforcement:Z-2822-2018
Official wording
Reason: Mislabeled hook pouch included a transport/storage label rather than the product label containing key product information such as part number, lot number, and expiration date, etc
Code information: Lot Number: 37LG1834 Exp. Date: 11Jan 2020
Distribution pattern: US Nationwide distribution
Derived failure modes
-
Labeling or packaging
Mislabeled