CareFusion 303, Inc. medical device recall: BD Alaris Systems Manager
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96323
- Recall initiated
- Feb 18, 2025
- Classified by FDA
- Mar 13, 2025
- Posted in Enforcement Report
- Mar 19, 2025
- Recalling firm
- CareFusion 303, Inc.
- Firm location
- San Diego, CA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 2
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Feb 18, 2025. FDA classified it 23 days later, on Mar 13, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None CareFusion 303, Inc. has 99 recalls in our records.
Recalled products (2)
Z-1304-2025 Class I Ongoing
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Codes / 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)
Z-1305-2025 Class I Ongoing
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
Codes / lots: Software: v1.7.2/UDI: 10885403510472
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96323
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.