Recall Z-1737-2022
Technomed Europe · initiated August 9, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Codes / lots: 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.
Reason for recall
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.
FDA-determined cause: Labeling Change Control
Action taken
The recalling firm issued letters dated 8/9/2022 that were flagged "MRI Safety Information." The letter provided an overview of the issue, the affected devices and lot numbers, a description of the issue including the MRI Safety Information that was added to the Instructions for Use, the hazard, and the actions to be taken. The actions included the consignee is to read the Field Safety Notice, review the list of affected products, inform customers who received or will receive products from the affected lot numbers about the issue by forwarding a copy of the notice and the updated Instructions for Use to them, and complete and sign the enclosed acknowledgment form to indicate they have read the notice, understand its content, and will follow the instructions as intended. The form is to be returned via email.
Details
- Recall number
- Z-1737-2022
- Initiated
- August 9, 2022
- Terminated
- April 11, 2024
- Product code
- IKT – Electrode, Needle, Diagnostic Electromyograph
- Quantity
- 37/25-electrode boxes
- Distribution
- US Nationwide distribution in the states of CA, FL, NH, OH, and WA.
- Recalling firm
- Technomed Europe, Maastricht-Airport