Reported Sep 21, 2022 · Terminated
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Technomed Europe
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Technomed Europe · Amerikalaan 71 · Maastricht-Airport · N/A
Is this the product you have?
- Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
- Lot codes and dates
Lot numbers 044220exp. 1/1/2023045077exp. 3/1/2023045443exp. 4/1/2023and 049285exp. 7/1/2024UDI-DI 08718375861530
- Amount recalled
- 37/25-electrode boxes
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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