BD Alaris Systems Manager , REF 9601 Infusion Safety… recallZ-1304-2025 · CareFusion 303, Inc. · initiated Feb 18, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1304-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 18, 2025
- Posted by the FDA
- Mar 13, 2025
- Recalling firm
- CareFusion 303, Inc.
- Product code
- PHC
- FDA submissions
- K211218
- 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 description
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Code information (models, lots, serial numbers)
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)
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Alaris 9601Carefusion 303, Inc. · Infusion safety management software2 recalls0 reports
- Alaris 9601Carefusion 303, Inc. · Pump, infusion1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 96323).
- Z-1305-2025 · Open, ClassifiedBD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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