FDA-Device2023-10-11Class II
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Bard Peripheral Vascular Inc
Hazard
Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly fitting into the coaxial cannula and accessing target tissue, which may lead to repeated procedure, and procedural complications, such as pain/discomfort, pneumothorax, and bleeding.
Sold states
Worldwide - US Nationwide distribution in the states of PR, CO, TX, CA, WA, OR, AZ, NJ, NY, OH, NC, MD, MI, LA, IN, AK, TN and the countries of CA, AU, BE.
Affected count
1,545
Manufactured in
1625 W 3rd St Bldg 1, N/A, Tempe, AZ, United States
Products
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0027-2024Don't want to check this manually?
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