Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Check against the official notice below — it lists the full affected range.
Technomed Europe is recalling disposable subdermal needle electrodes (product number TE/S46/638, 25 needles per package) distributed nationwide in California, Florida, New Hampshire, Ohio, and Washington. The recall affects 37 boxes of these sterile electrodes across four lot numbers: 044220 (expiration 1/1/2023), 045077 (expiration 3/1/2023), 045443 (expiration 4/1/2023), and 049285 (expiration 7/1/2024). The electrodes are identified by UDI-DI 08718375861530.
The electrodes pose a hazard because patients can suffer burns of varying degrees if the electrodes are left in place while undergoing an MRI scan, due to inadequate safety information in the instructions for use. The source does not specify what remedy is available to affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Nationwide distribution in the states of CA, FL, NH, OH, and WA. Quantity: 37/25-electrode boxes Lot/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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.