Angiodynamics Inc. (Navilyst Medical Inc.) recalls TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567

Recall date

May 10, 2018

Source

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

Recall number

Z-2206-2018

FDA classification

Class II

Brand / firm

Angiodynamics Inc. (Navilyst Medical Inc.)

Sold / distributed

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.

Why it was recalled

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

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

What was recalled

TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567