CLASS I ONGOING Device recall · Reported 19 Mar 2025 · FDA Enforcement Report

BD Alaris Systems Manager recalled by CareFusion 303

CareFusion 303 is recalling BD Alaris Systems Manager, distributed in 21 states. The recall was initiated on 18 Feb 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesSoftware v12.5.1 or v12.5.2, and prior versions (4.33, 12.0.1, 12.0.2, 12.1, 12.1.2, 12.3) UDIs: 10885403960123 10885403519666 (10885403960116)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1304-2025
FDA event ID: 96323
Recalling firm: CareFusion 303, San Diego, CA
Classification: Class I
Status: Ongoing
Recall initiated: 18 Feb 2025
FDA classified: 13 Mar 2025
Reported: 19 Mar 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

18 Feb 2025	Recall initiated by company
13 Mar 2025	Classified by FDA	+23 days
19 Mar 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

Where it was distributed

US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None

Arizona California District of Columbia Florida Georgia Illinois Indiana Michigan Missouri North Carolina New Jersey New York Ohio Oregon Pennsylvania South Carolina Texas Utah Virginia Washington

Questions about this recall

Is BD Alaris Systems Manager recalled?

Yes. CareFusion 303 recalled BD Alaris Systems Manager on 18 Feb 2025. The recall is Class I and its status is Ongoing. Recall number Z-1304-2025.

Why was it recalled?

Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

Which lots are affected?

Software v12.5.1 or v12.5.2, and prior versions (4.33, 12.0.1, 12.0.2, 12.1, 12.1.2, 12.3) UDIs: 10885403960123 10885403519666 (10885403960116)

Where was it sold?

US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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