FHC, Inc.: Device Recall
Recall #Z-0312-2025 · 10/04/2024
Class I: Dangerous
Recall Details
- Recall Number
- Z-0312-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- FHC, Inc.
- Status
- Ongoing
- Date Initiated
- 10/04/2024
- Location
- Bowdoin, ME, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 packs of 5ea (40 total)
Reason for Recall
A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage.
Product Description
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
Distribution Pattern
Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.