NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number:...
FDA Device Recall #Z-2822-2018 — Class II — June 19, 2018
Recall Summary
| Recall Number | Z-2822-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 19, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Nico Corp. |
| Location | Indianapolis, IN |
| Product Type | Devices |
| Quantity | 204 devices |
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
Distribution Pattern
US Nationwide distribution
Lot / Code Information
Lot Number: 37LG1834 Exp. Date: 11Jan 2020
Other Recalls from Nico Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1840-2021 | Class II | Myriad-LX Light Source-for delivery of light to... | Apr 30, 2021 |
| Z-1839-2021 | Class II | NICO Myriad-LX Illumination Pack: REF: NN-1000... | Apr 30, 2021 |
| Z-2767-2015 | Class II | NICO Myriad Console Model number NN-7000 T... | Jul 29, 2015 |
| Z-2045-2016 | Class II | Myriad handpiece Tissue morcellator | Feb 24, 2014 |
| Z-2201-2012 | Class II | 13.5 mm x 60 mm BrainPath Sheath The NICO Br... | Jul 17, 2012 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.