Recall Z-2427-2020— Argon Medical Devices, Inc

Name: FDA recall Z-2427-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-02

Class II · Terminated

Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2019-12-02, terminated 2022-11-09. It names one FDA 510(k) clearance: K904987. 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: Incorrect product labeling..

Recalling firm: Argon Medical Devices, Inc
Classification: Class II
Status: Terminated
Initiated: 2019-12-02
Terminated: 2022-11-09
Firm location: Athens, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K904987 — VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)Vibronics·cleared 1991-02-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.