FHC, Inc. is recalling 40 units (8 packs of 5) of the microTargeting Insertion Tube Set (Part Number 66-IT-05P) from Lot 244517. The devices contain a spacer tube that was manufactured too long, which could cause surgical instruments to penetrate deeper into the brain than intended. One complaint has been received regarding this defect, which was discovered after an investigation into build orders.
Using a spacer tube that is too long can lead to instruments reaching unintended areas of the brain, potentially causing internal bleeding (intracranial hemorrhaging) and permanent brain damage.
Correction or Replacement
Investigation involved a schematic error for P/N 66-IT-06P included in the build order for Lot 244517.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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