Class 2 Device Recall BioPince Full Core Biopsy Instrument

• Date Initiated by Firm: December 02, 2019
• Create Date: June 25, 2020
• Recall Status: Terminated on November 09, 2022
• Recall Number: Z-2427-2020
• Recall Event ID: 85426
• 510(K)Number: K904987
• Product Classification: Instrument, biopsy - Product Code KNW
• 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.
• Code Information: Lot No.: 11277175; Model # 370-1580-01, 16ga x 15cm, for use with Optional Co-axial Needle MCXS1615BP
• Recalling Firm/ Manufacturer: Argon Medical Devices, Inc; 1445 Flat Creek Rd; Athens TX 75751-5002
• For Additional Information Contact: Rebecca Ellis; 469-731-1410
• Manufacturer Reason for Recall: Incorrect product labeling.
• FDA Determined 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: Amy.Wheeler@argonmedical.com; or Public Contact Information, Rebecca Ellis, VP, RA/QA, Argon Medical Devices 1-469-731-1410 Beckie.Ellis@argonmedical.com 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KNW