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Terminated

NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024

FDA Recall Z-2822-2018 · Posted None

Recalling FirmNico Corp.
Recall StatusTerminated
Product CodeGZT
Date Initiated2018-06-19
Date Terminated2018-11-09
Product Quantity204 devices

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

Firm Action

On June 19, 2018 , NICO issued letter by mail and/or email letters to consignees that have received hooks from the affected lot. The letter provides instructions to inspect all of its current stock of NN-8024, Greenberg Hooks for the proper pouch label. if an incorrect label is discovered, the hook should be removed from stock and returned to NICO. Questions or need additional information, please contact [email protected] or 317-660-7118 ext. 104.

Root Cause

Packaging process control

Distribution Pattern

US Nationwide distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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