Radiometer Medical ApS recalls ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004

Recall date

March 6, 2020

Source

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

Recall number

Z-1836-2020

FDA classification

Class II

Brand / firm

Radiometer Medical ApS

Sold / distributed

US: in the state of California

Why it was recalled

Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.

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

What was recalled

ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004