The Recall Desk
ModerateFDA (Devices)·Z-1239-2016·Announced 2016-03-30

CareFusion Recalls Alaris PC Infusion Pump Units Due to Power Supply Error

CareFusion is recalling 170 Alaris PC Unit Infusion Pump Model 8000 devices because a power supply component may cause system error codes.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional error code without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

CareFusion 303, Inc. is recalling 170 units of the Alaris PC Unit, Infusion Pump Model 8000 (Part No. TC10005092). The recall is being conducted because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).

The affected devices were distributed nationwide in the United States, including in the states of AR, AZ, CA, FL, GA, IN, KY, MD, MI, MN, MO, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, and WI. The recall is classified as Class II by the FDA.

Healthcare facilities and users should check their inventory for the specific serial numbers listed in the official recall notice. If a device is affected, users should stop using it and contact CareFusion for further instructions.

The recalled product

Product
Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
170

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

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