Z-2427-2020 Class II Terminated
FDA device recall Z-2427-2020 was initiated by Argon Medical Devices, Inc on December 2, 2019 and is designated Class II. Reason for recall: Incorrect product labeling. The recall status is terminated (terminated November 9, 2022). Affected quantity: 165 units in U.S. and 330 units Internationally.
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