Recall Z-0221-2025
Ad-Tech Medical Instrument Corporation · initiated September 19, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Codes / lots: UDI/DI 00841823107688, Lot Number 168788 855856857, 172999 873874875R, 174915 879880881
Reason for recall
Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.
FDA-determined cause: Employee error
Action taken
AD-TECH issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 09/19/2024. The notice explained the problem with the devices, risk to health, and requested the consignee contact customer support to obtain an RMA to expedite the return of the affected product. For questions: contact your Ad-Tech Clinical Specialist.
Details
- Recall number
- Z-0221-2025
- Initiated
- September 19, 2024
- Posted by FDA
- October 24, 2024
- Product code
- GZL – Electrode, Depth
- Quantity
- 14 units
- Distribution
- US Nationwide distribution in the states of CA, OH.
- Recalling firm
- Ad-Tech Medical Instrument Corporation, Oak Creek, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0219-2025 Class II | AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style)…Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style… | 09/19/2024Completed |
| Z-0220-2025 Class II | AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style)…Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style… | 09/19/2024Completed |