BEST THERATRONICS LTD. recalls Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in tr…

Recall date

May 6, 2016

Source

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

Recall number

Z-2251-2016

FDA classification

Class II

Brand / firm

BEST THERATRONICS LTD.

Sold / distributed

Nationwide

Why it was recalled

It was discovered that both the new device and the predicate device failed to comply with performance standard.

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

What was recalled

Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.