Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error" or "Missing Battery Error" at start up. The error code is accompanied…"

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: malfunction

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.

Same manufacturer · CareFusion 303, Inc.

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