FDA-Device2021-03-31Class II
BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents
Bard Peripheral Vascular Inc
Hazard
Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.
Sold states
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY O.U.S.: Australia, Belgium, Canada, Europe, India, and Singapore
Affected count
Total 131,876 kits (102,210 kits U.S. and 29,666 kits O.U.S.)
Manufactured in
1625 W 3rd St Bldg 1, N/A, Tempe, AZ, United States
Products
BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1289-2021Don't want to check this manually?
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