Product Safety Recalls

Product Recall Tracker

Technomed Europe Recall 90733

Description: Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.

Technomed Europe Recall 90733 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1737-2022
Event ID90733
Event DescriptionDisposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Product TypeDevices
DistributionUS Nationwide distribution in the states of CA, FL, NH, OH, and WA.
Quantity37/25-electrode boxes
Recall ReasonBurns 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.
Device Classification20220921
Device Code InfoLot 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.
Center Classification Date20220912
Recall Initiation Date20220809
Recalling FirmTechnomed Europe
Initial Notification Letter
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.