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FHC, Inc.
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for FHC, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-11-20FDA-DeviceClass ImicroTargeting 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.
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.
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