Reported Nov 20, 2024 · Ongoing
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode…
FHC, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: FHC, Inc. · 1201 Main St · Bowdoin, ME · 04287-7302
Is this the product you have?
- 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.
- Lot codes and dates
- Package DI10873263004323
- Contains DI Package00873263004326 LOT No. 244517
- Amount recalled
- 8 packs of 5ea (40 total)
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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