FHC, Inc.: 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 neurosurgica

Hazard

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.

Details from the source

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. Distribution: Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA. Quantity: 8 packs of 5ea (40 total) Lot/code info: Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517

UPC codes

10873263004323, 00873263004326

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.