Z-2427-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2020
- Initiation Date
- December 2, 2019
- Termination Date
- November 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 165 units in U.S. and 330 units Internationally
Product Description
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.
Reason for Recall
Incorrect product labeling.
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.
Code Information
Lot No.: 11277175; Model # 370-1580-01, 16ga x 15cm, for use with Optional Co-axial Needle MCXS1615BP