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Technomed Europe recalls Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, an
Recalled January 19, 2022 · FDA recall Z-0465-2022 · 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. · FDA Class II
Units
117,672 devices
Sold at
US Nationwide distribution in the states of California, Florida, and Ohio.
Description
There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
Product
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Manufacturer(s)
Technomed Europe
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →