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Angiodynamics Inc. (Navilyst Medical Inc.) recalls RS TANDEM 5F DL XPP, Catalog Number 60M019881
Recalled June 20, 2018 · FDA recall Z-2200-2018 · Angiodynamics Inc. (Navilyst Medical Inc.)
Hazard
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). · FDA Class II
Units
7
Sold at
The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
Description
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Product
RS TANDEM 5F DL XPP, Catalog Number 60M019881
Manufacturer(s)
Angiodynamics Inc. (Navilyst Medical Inc.)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →