Z-2427-2020Class II

BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS -

Name: Z-2427-2020 BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS -
Creator: Argon Medical Devices, Inc
Published: 2019-12-02
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2019-12-02 / Terminated / root cause: labeling and UDI

FDA source

Argon Medical Devices, Inc began a recall of BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince... on 2019-12-02. FDA classified it as Class II and gives the reason as "Incorrect product labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2427-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-02
Posted: 2020-06-25
Terminated: 2022-11-09
Recalling firm: Argon Medical Devices, Inc
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.
Product code: KNW Instrument, Biopsy
Reason for recall: Incorrect product labeling.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On December 2, 2019, the firm sent out a "NOTIFICATION OF RECALL" to customers via registered mail, informing customers of the wrong/incorrect, label on the device. The firm requested to their customers to complete the recall form and return it to the firm with the packaged, unused devices. Customers were instructed to inspect, quarantine and return any affected product remaining at their facility utilizing the instruction on the "Recall Response Form". Customers were also instructed to complete the response acknowledgement form included with the letter and return by fax, mail or email as soon as possible to the firm at address provided and to the attention of : Ms. Amy Clendening-Wheeler, RA Manager, email: [email protected]; or Public Contact Information, Rebecca Ellis, VP, RA/QA, Argon Medical Devices 1-469-731-1410 [email protected] Customers were instructed to pass the notice on to all those who need to be aware within their organization or to any organization to which the potentially affected devices have been transferred. For those products in global distribution, Argon to contact the relevant foreign regulatory bodies and conduct similar notifications of foreign distributors on a country by country basis. Returned goods to be reworked with correct labeling. Rework instruction/procedure has been requested by FDA.
Quantity in commerce: 165 units in U.S. and 330 units Internationally
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.
Product codes and lots: Lot No.: 11277175; Model # 370-1580-01, 16ga x 15cm, for use with Optional Co-axial Needle MCXS1615BP

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2427-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2427-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-01	2020-06-25

Product code KNW

K904987Class IIVibronics Auto Core Biopsy Device (Acbd)Vibronics / cleared 1991-02-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)