Bard Peripheral Vascular Inc recalls Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicated for use in the prevention of recurrent pul…

Recall date

February 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1069-2016

FDA classification

Class II

Brand / firm

Bard Peripheral Vascular Inc

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.