FDA recall Z-0465-2022

Technomed Europe · Class II · device

Product

Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.

Reason for recall

There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.

Distribution

US Nationwide distribution in the states of California, Florida, and Ohio.

Key facts

Status
Terminated
Initiation date
2021-12-08
Report date
2022-01-19
Termination date
2024-05-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Maastricht-Airport, N/A, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0465-2022