The Recall Desk
HighFDA (Devices)·Z-2741-2020·Announced 2020-08-12

CareFusion Alaris System PC Unit Model 8015 Infusion Pump Recall

CareFusion is recalling Alaris System PC Unit Model 8015 infusion pumps because loose or missing screws may cause power loss and therapy interruption.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a mechanical defect could cause power loss and interruption of patient therapy or monitoring. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

CareFusion 303, Inc. is recalling the Alaris System PC Unit Model 8015 modular infusion pump and monitoring system. The recall involves 824,277 units distributed across the United States and numerous international locations.

The recall is due to a potential issue where one or more screws or washers may be loose or missing, causing the battery not to be properly secured to the PC Unit. If the system is running on battery power, this condition may result in a power loss accompanied by a prolonged, non-silenceable alarm. This power loss may lead to an interruption of patient therapy or monitoring.

Healthcare facilities and users of these devices should check their Alaris System PC Unit Model 8015 units for loose or missing screws or washers securing the battery. CareFusion has not reported any illnesses or injuries associated with this defect.

The recalled product

Product
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
824,277

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)

  • All serial numbers

Distribution

Distributed in 55 states:

Part of a larger recall action

This product is one of 2 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · power loss

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