RanD S.r.l. recalls Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120

Recall date

April 30, 2021

Source

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

Recall number

Z-2048-2021

FDA classification

Class II

Brand / firm

RanD S.r.l.

Sold / distributed

The products were distributed to the following US states: FL, IL, TN, WI

Why it was recalled

The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.

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

What was recalled

Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120