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Cardinal Health 200, LLC recalls Femoral Angiography Drape Bulk Non-Sterile

Recalled March 31, 2021 · FDA recall Z-1304-2021 · Cardinal Health 200

Hazard
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly. · FDA Class II
Units
83213 units
Sold at
Distributed nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Distributed also to Australia and Canada.

Description

Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.

Product
Femoral Angiography Drape Bulk Non-Sterile
Manufacturer(s)
Cardinal Health 200, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov