FDAClass IIAugust 22, 2018

NICO Shepherd' s Hook - Greenberg recall: Labeling Error

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

Why was NICO Shepherd' s Hook - Greenberg 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 37LG1834 Exp. Date: 11Jan 2020

Product
NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
Recalling firm
Nico Corp.
Quantity
204 devices
Distribution
US Nationwide distribution
Recall date
August 22, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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