The Recall Desk
ModerateFDA (Devices)·Z-2076-2012·Announced 2012-08-01

CareFusion Alaris PC Unit Model 8015 Recalled for Power Supply Board Error

CareFusion 303, Inc. is recalling Alaris PC unit model 8015 devices because a power supply board component causes startup error codes and alarms.

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 I, which typically indicates a low risk of adverse health consequences. The defect causes error codes and alarms but no injuries or illnesses are reported in the source text.

Plain-English summary

CareFusion 303, Inc. is recalling the Alaris PC unit model 8015, a prescription-only medical device. The recall involves 112,912 units total, with 106,888 units distributed in the United States. The devices were distributed nationwide.

The recall was initiated because a component on the PC unit power supply board is causing an error code (120.4630) labeled "System Error" or "Missing Battery Error" at startup. This error is accompanied by an audible alarm and visual error messages on the PC unit screen.

The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the defect.

The recalled product

Product
Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • not available

Distribution

Distributed nationwide across the United States.

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