AD-TECH Spencer Probe Depth Electrode recall
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Why was AD-TECH Spencer Probe Depth Electrode recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00841823107688, Lot Number 168788 855856857, 172999 873874875R, 174915 879880881
- Product
- AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
- Recalling firm
- Ad-Tech Medical Instrument Corporation
- Quantity
- 14 units
- Distribution
- US Nationwide distribution in the states of CA, OH.
- Recall date
- October 30, 2024
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)