FDA recall Z-1877-2018

Product

Trident Endoscopic Ultrasonic Biopsy Needle (FNB)

Reason for recall

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.

Distribution

US distribution to one distributor in MI.

Key facts

Status

Terminated

Initiation date

2018-03-12

Report date

2018-05-23

Termination date

2018-08-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nanjing, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1877-2018