FDA-Device2020-07-01Class II
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.
Argon Medical Devices, Inc
Hazard
Incorrect product labeling.
Sold states
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.
Affected count
165 units in U.S. and 330 units Internationally
Manufactured in
1445 Flat Creek Rd, N/A, Athens, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2427-2020Don't want to check this manually?
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