The Recall Desk
ModerateFDA (Devices)·Z-2822-2018·Announced 2018-08-22

Nico Corp. Recalls Mislabeled Sterile Shepherd's Hook Accessories

Nico Corp. is recalling 204 sterile Shepherd's Hook accessories because they were shipped with incorrect transport labels instead of product labels.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a labeling error that omits critical product identification data, which fits the criteria for a moderate severity recall involving minor labeling errors or precautionary measures.

Plain-English summary

Nico Corp. is recalling 204 units of the NICO Shepherd's Hook - Greenberg, sterile (Part Number: NN-8024). This accessory is used with the NICO BrainPath device. The recall covers Lot Number 37LG1834 with an expiration date of 11Jan 2020. The devices were distributed nationwide in the United States.

The recall was initiated because the hook pouches included a transport and storage label rather than the required product label. The missing product label failed to display key information, including the part number, lot number, and expiration date.

Healthcare facilities and distributors should identify any affected units by checking for the specific lot number and expiration date. Users should stop using the affected devices and contact Nico Corp. for instructions on return or replacement.

The recalled product

Product
NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
Manufacturer
Nico Corp.
Affected units
204

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.