Z-1304-2025Class I

BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

Name: Z-1304-2025 BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Creator: CareFusion 303, Inc.
Published: 2025-02-18
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2025-02-18 / Open, Classified / root cause: software

FDA source

CareFusion 303, Inc. began a recall of BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software on 2025-02-18. FDA classified it as Class I and gives the reason as "Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1304-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-02-18
Posted: 2025-03-13
Recalling firm: CareFusion 303, Inc
Product: BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Product code: PHC Infusion Safety Management Software
Reason for recall: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: On February 18, 2025, Becton, Dickinson issued a " Urgent Medical Device Product Correction" Notification. to affected consignees via Fed-Ex and E-Mail. 1. Users should review all infusion parameters pre-populated and confirm they are correct before pressing START as stated in the BD Alaris User Manual. 2. Disseminate this notice within your facility network to ensure that all concerned personnel are made aware of this issue. 3. BD Project Managers will engage with you to address any questions regarding this notice, and specific next steps for your facility. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form, regardless of whether you have any of the impacted material. This will allow BD to confirm receipt of this notification. 5. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program.
Distribution: US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1304-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1304-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-13
Z-1305-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-13

Product code PHC

K211218Class IIBD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. / cleared 2023-07-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)