FDAMay 10, 2018device

RS TANDEM 5F DL XPP, Catalog Number 60M019881

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

angiodynamics inc navilyst medical incangiodynamicsangiodynamics inc

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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