The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

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: "During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted."

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…
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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