FDA-Device2021-03-31Class II
Femoral Angiography Drape Sterile
Cardinal Health 200, LLC
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.
Sold states
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.
Affected count
936 units
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
Femoral Angiography Drape Sterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1303-2021Don't want to check this manually?
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