FDA-Device2018-06-20Class II
RS 5F DL BIOFLO PASV, Catalog Number 60M161567
Angiodynamics Inc. (Navilyst Medical Inc.)
Hazard
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Sold states
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.
Affected count
2 boxes
Manufactured in
10 Glens Falls Tech Park, N/A, Glens Falls, NY, United States
Products
RS 5F DL BIOFLO PASV, Catalog Number 60M161567
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2209-2018Don't want to check this manually?
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