FDA recall Z-1737-2022

Product

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

US Nationwide distribution in the states of CA, FL, NH, OH, and WA.

Key facts

Status

Terminated

Initiation date

2022-08-09

Report date

2022-09-21

Termination date

2024-04-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maastricht-Airport, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1737-2022