Recall Z-0499-2009
FHC, Inc. · initiated October 20, 2008
Product
FC400SP microTargeting StimPilot Single Procedure Kit Distributed by Medtronic Inc., Minneapolis, MN Ref: FHC4000SP Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.
Codes / lots: Serial numbers: 01689 through 01708 and 01756 through 01758.
Reason for recall
Mislabeled: May contain an electrode longer than labeled size
FDA-determined cause: Pending
Action taken
FHC notified customers via an Urgent: Medical Device Recall letter dated 10/20/08 advising users to remove the recalled electrodes from inventory and set the product aside for inspection by your FHC representative. Customers were asked to document their actions by completing the enclosed form and faxing it back to FHC at 207-666-8539.
Details
- Recall number
- Z-0499-2009
- Initiated
- October 20, 2008
- Posted by FDA
- December 18, 2008
- Terminated
- May 2, 2012
- Product code
- GZL – Electrode, Depth
- Quantity
- 23 kits (46 electrodes-2 electrodes/kit)
- Distribution
- Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR.
- Recalling firm
- FHC, Inc., Bowdoinham, ME
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0497-2009 | FHC MicroTargeting Electrode, MTDWBP(AR)(MP I ) Intended for use in intra-operative…Mislabeled: May contain an electrode longer than labeled size | 10/20/2008Terminated |
| Z-0498-2009 | FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and Nexdrive Distributed by…Mislabeled: May contain an electrode longer than labeled size | 10/20/2008Terminated |