Disposable Subdermal Needle Electrode recall
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Why was Disposable Subdermal Needle Electrode recalled?
Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.
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?
Lot numbers 044220, exp. 1/1/2023; 045077, exp. 3/1/2023; 045443, exp. 4/1/2023; and 049285, exp. 7/1/2024; UDI-DI 08718375861530.
- Product
- Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
- Recalling firm
- Technomed Europe
- Quantity
- 37/25-electrode boxes
- Distribution
- US Nationwide distribution in the states of CA, FL, NH, OH, and WA.
- Recall date
- September 21, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)