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.
- Company
- Fhc, Inc.
- Recall Initiated
- October 4, 2024
- Posted
- November 8, 2024
- Recall Number
- Z-0312-2025
- Quantity
- 8 packs of 5ea (40 total)
- Firm Location
- Bowdoin, ME
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.
Lot / Code Info
Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517
Root Cause
Process change control
Action Taken
On October 4, 2024, the firm notified affected consignees via Urgent Medical Device Recall letters. Customers were instructed to immediately identify and quarantine all affected product. The firm will contact customers and issue an RMA to return affected product and issue a replacement by 10/11/24. Customers should not use the product in the interim. Should you have any further questions regarding this matter you may contact the firm by email at kmoeykens@fh-co.com or by telephone at 207-666-5425.