NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
This recall is currently active, issued September 12, 2024. It was issued by Technomed Europe Amerikalaan 71 Maastricht-Airport Netherlands.
- Recall Initiated
- July 25, 2024
- Posted
- September 12, 2024
- Recall Number
- Z-3131-2024
- Quantity
- 71 units
- Official Source
- View on FDA website ↗
Reason for Recall
Product has have presence of brown discoloration or substance on the hinge area of the device
Distribution
US: FL, CA, TX, IL, NY, PA, MA
Lot / Code Info
UDI/DI 08718375869659, Lot Numbers: 061158, 061380
Root Cause
Process control
Action Taken
Technomed Europe issued a FIELD SAFETY NOTICE to its consignees on 07/25/2024 via email. The notice explained the issue, potential risk, and requested the cessation of distribution and quarantine of the affected product pending return of the affected product. Distributors were directed to notify those to whom the product was distributed by forwarding a copy of the notice.