Medical device recalls Moderate risk

NICO Shepherd' s Hook - Greenberg recalled over labeling errors

Recall date
June 19, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Nico Corp. recalls NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
Recall number
Z-2822-2018
FDA classification
Class II
Brand / firm
Nico Corp.
Sold / distributed
US Nationwide distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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