FDA recall Z-2427-2020

Product

BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, abdominal masses, etc.

Reason for recall

Incorrect product labeling.

Distribution

Worldwide distribution - US Nationwide including in the states of TX, IL, FL, KS, MD, CA, WA, NY, WI, PA and the countries of United Arab Emirates (Dubai), Spain, Canada.

Key facts

Status

Terminated

Initiation date

2019-12-02

Report date

2020-07-01

Termination date

2022-11-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Athens, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2427-2020