FDA-Device2016-03-16Class II
Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
Bard Peripheral Vascular Inc
Hazard
Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali Filter-Femoral Delivery System because of the stop cocks potentially cracking.
Sold states
Worldwide Distribution-US (nationwide) including DC and PR, and the states of MN, TX, PA, OH, IL, OR, CA, SC, NC, AK, NY, MD, GA, NJ, AZ, KY, OH, WI, AL, AR, MO, FL, MA, MT, TN, LA, CT, NE, WV, VA, NV, ME, UT, CO, WY, AR, DE, NM, IN, MN, MS, NH, IA, MI, WA, VA, KS, HI, RI, SD, VT, and the countries of Hong Kong, Malaysia, Canada, Chile.
Affected count
2904
Manufactured in
1625 W 3rd St, N/A, Tempe, AZ, United States
Products
Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1068-2016Don't want to check this manually?
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