Z-2822-2018 Class II Terminated
FDA device recall Z-2822-2018 was initiated by Nico Corp. on June 19, 2018 and is designated Class II. Reason for recall: 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 The recall status is terminated (terminated November 9, 2018). Affected quantity: 204 devices.
Recall Details
- Product Type
- Devices
- Report Date
- August 22, 2018
- Initiation Date
- June 19, 2018
- Termination Date
- November 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 204 devices
Product Description
NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
Reason for Recall
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
Distribution Pattern
US Nationwide distribution
Code Information
Lot Number: 37LG1834 Exp. Date: 11Jan 2020