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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1737-2022 |
| Event ID | 90733 |
| Event Description | Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, FL, NH, OH, and WA. |
| Quantity | 37/25-electrode boxes |
| Recall Reason | 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. |
| Device Classification | 20220921 |
| Device Code Info | 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. |
| Center Classification Date | 20220912 |
| Recall Initiation Date | 20220809 |
| Recalling Firm | Technomed Europe |
| Initial Notification | Letter |
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