FDA recall Z-2822-2018

Product

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

US Nationwide distribution

Key facts

Status

Terminated

Initiation date

2018-06-19

Report date

2018-08-22

Termination date

2018-11-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2822-2018