Alaris Pump Module Model 8100 — recall Z-2736-2020
U.S. FDA — Device Enforcement · United States · 2020-06-30 · Class I
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Reported risk: Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.
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