—#180820

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.

FDA product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K904987
Affected lot / code info: Lot No.: 11277175; Model # 370-1580-01, 16ga x 15cm, for use with Optional Co-axial Needle MCXS1615BP

Why it was recalled

Incorrect product labeling.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751-5002

Distribution

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.

Timeline

Recall initiated: 2019-12-02
Terminated: 2022-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180820. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.