FDAFDA · Food and drugs·Recall number Z-0312-2025
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.
Published November 20, 2024 · Recall initiated: October 4, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- FHC, Inc.
- Distributor
- Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.
- Lot
- Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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