Z-1737-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 21, 2022
- Initiation Date
- August 9, 2022
- Termination Date
- April 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37/25-electrode boxes
Product Description
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
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 Pattern
US Nationwide distribution in the states of CA, FL, NH, OH, and WA.
Code Information
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.