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.
Reported: July 1, 2020 Initiated: December 2, 2019 #Z-2427-2020
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.
Details
- Recalling Firm
- Argon Medical Devices, Inc
- Units Affected
- 165 units in U.S. and 330 units Internationally
- Distribution
- 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.
- Location
- Athens, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Argon Medical Devices, Inc. Units affected: 165 units in U.S. and 330 units Internationally.
Why was this product recalled? ▼
Incorrect product labeling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2020. Severity: Moderate. Recall number: Z-2427-2020.
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