The Biomed Guys recalls Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIP…

Recall date

March 25, 2021

Source

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

Recall number

Z-1651-2021

FDA classification

Class I

Brand / firm

The Biomed Guys

Sold / distributed

Us distribution to the states of IN and TX.

Why it was recalled

Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.