FHC MicroTargeting Electrode, MTDWBP(AR)(MP I ) Intended for use in intra-operative recording of single unit neuronal ac
FDA device recall Z-0497-2009 · posted 2008-12-18 · Terminated
Recall details
- Recalling firm
- FHC, Inc.
- Reason for recall
- Mislabeled: May contain an electrode longer than labeled size
- 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.
- Root cause
- Pending
- Status
- Terminated
- Product code
- GZL
- Quantity affected
- 36 units (180 Electrodes-5 per package)
- Distribution
- Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR.
- Date initiated
- 2008-10-20
- Date posted
- 2008-12-18
- Date terminated
- 2012-05-02
- Location
- Bowdoinham, ME
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROTARGETING ELECTRODE (K991522) | FHC, Inc. | 2000-08-04 |