microTargeting Insertion Tube Set recall
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…
Why was microTargeting Insertion Tube Set recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517
- Product
- 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…
- Recalling firm
- FHC, Inc.
- Quantity
- 8 packs of 5ea (40 total)
- Distribution
- Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.
- Recall date
- November 20, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)