The Recall Desk
ModerateFDA (Devices)·Z-1311-2015·Announced 2015-04-01

CareFusion Recalls Alaris PC Infusion Pumps Due to Keypad Error Code

CareFusion 303, Inc. is recalling 56,015 Alaris PC infusion pumps because a keypad issue may trigger an error code during the power-on self-test.

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. The hazard is a functional error code during self-test with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

CareFusion 303, Inc. is recalling 56,015 units of the Alaris PC infusion pump, Model No. 8015. The recall was initiated due to a potential keypad issue that may cause an error code to appear upon power-on during the "Power-On Self Test."

The affected units were distributed worldwide, including in the United States, Canada, the European Union, Singapore, and Australia. The source text does not specify any reported illnesses, injuries, or deaths associated with this defect.

Healthcare facilities and users should check their device serial numbers against the list provided in the official recall notice to determine if their units are affected. The source text does not provide specific consumer instructions for remediation, such as repair or replacement protocols.

The recalled product

Product
Alaris PC units, Model No. 8015. Infusion pump.
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
56,015

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · CareFusion 303, Inc.

See all →

Same hazard · malfunction

See all →