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Bard Peripheral Vascular Inc recalls Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Recalled October 11, 2023 · FDA recall Z-0027-2024 · Bard Peripheral Vascular
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. · FDA Class II
Units
1,545
Sold at
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.
Description
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.
Product
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Manufacturer(s)
Bard Peripheral Vascular Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →