Z-2427-2020 Class II Terminated

Recalled by Argon Medical Devices, Inc — Athens, TX

Recall Details

Product Type
Devices
Report Date
July 1, 2020
Initiation Date
December 2, 2019
Termination Date
November 9, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
165 units in U.S. and 330 units Internationally

Product Description

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 Pattern

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.

Code Information

Lot No.: 11277175; Model # 370-1580-01, 16ga x 15cm, for use with Optional Co-axial Needle MCXS1615BP