Device 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.
Z-2427-2020
Product summary
- Event
- Event 85426
- Status
- Terminated
- Classification
- Class II
- Quantity
- 165 units in U.S. and 330 units Internationally
- Official record key
device-enforcement:Z-2427-2020
Official wording
Reason: Incorrect product labeling.
Code information: Lot No.: 11277175; Model # 370-1580-01, 16ga x 15cm, for use with Optional Co-axial Needle MCXS1615BP
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.
Derived failure modes
-
Labeling or packaging
Incorrect product labeling