The Recall Desk
HighFDA (Devices)·Z-0950-2017·Announced 2017-01-25

CareFusion Recalls Alaris Pump Modules Due to False Air-in-Line Alarms

CareFusion is recalling Alaris Pump Modules and AIL sensor kits because false Air-in-Line alarms can interrupt medication infusions.

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 malfunction (false alarm) interrupts medication delivery. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

CareFusion 303, Inc. is recalling Alaris Pump Modules, Model No. 8100, and AIL sensor kits (P/N 147083-102 and P/N 49000221). The recall covers 382,635 units that were distributed nationwide. The affected products were manufactured or serviced between October 2011 and June 2015.

The recall was initiated because a false Air-in-Line (AIL) alarm may occur during an infusion. This malfunction causes the infusion to be interrupted, which can disrupt the delivery of medication and fluids to patients.

Healthcare facilities and consumers should stop using the affected Alaris Pump Modules and AIL sensor kits. CareFusion is the recalling firm and is responsible for managing the recall process.

The recalled product

Product
Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuou
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
382,635

Distribution

Distributed nationwide across the United States.

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