FDAMarch 3, 2021device

BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.

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

The hazard

Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in infusion interruption/start delay

What to do

FDA enforcement status: Ongoing

Brands named

carefusion 303carefusion

Recall history

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

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