FDAClass IIMay 23, 2018

Trident Endoscopic Ultrasonic Aspiration Needle recall

Trident Endoscopic Ultrasonic Aspiration Needle (FNA)

Why was Trident Endoscopic Ultrasonic Aspiration Needle 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Identifier EUS-22-0-N UPN ES34601 M171226172

Product
Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
Recalling firm
Micro-Tech (Nanjing) Co., Ltd.
Quantity
40 total
Distribution
US distribution to one distributor in MI.
Recall date
May 23, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls