FDA-Device2022-01-19Class II
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Technomed Europe
Hazard
There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
Sold states
US Nationwide distribution in the states of California, Florida, and Ohio.
Affected count
117,672 devices
Manufactured in
Amerikalaan 71, N/A, Maastricht-Airport, N/A, Netherlands
Products
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0465-2022Don't want to check this manually?
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