Micro-Tech (Nanjing) Co., Ltd. recalls Trident Endoscopic Ultrasonic Aspiration Needle (FNA)

Recall date

March 12, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1878-2018

FDA classification

Class II

Brand / firm

Micro-Tech (Nanjing) Co., Ltd.

Sold / distributed

US distribution to one distributor in MI.

Why it was recalled

The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Trident Endoscopic Ultrasonic Aspiration Needle (FNA)