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.
This recall has been terminated (originally issued December 18, 2008).
- Company
- Fhc, Inc.
- Recall Initiated
- October 20, 2008
- Posted
- December 18, 2008
- Terminated
- May 2, 2012
- Recall Number
- Z-0499-2009
- Quantity
- 23 kits (46 electrodes-2 electrodes/kit)
- Firm Location
- Bowdoinham, ME
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeled: May contain an electrode longer than labeled size
Distribution
Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR.
Lot / Code Info
Serial numbers: 01689 through 01708 and 01756 through 01758.
Root 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.
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