Recall Z-2822-2018— Nico Corp.

Name: FDA recall Z-2822-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-19

Class II · Terminated

Class II FDA medical device recall by Nico Corp., initiated 2018-06-19, terminated 2018-11-09. FDA's recall record names no specific 510(k) clearance for this event. Product: NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024. 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.

Recalling firm: Nico Corp.
Classification: Class II
Status: Terminated
Initiated: 2018-06-19
Terminated: 2018-11-09
Firm location: Indianapolis, IN, United States

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.