Recall Z-1305-2025 ยท PHC Infusion Safety Management Software
CareFusion 303, Inc.
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
| Date | Mar 13, 2025 (initiated Feb 18, 2025) |
| Status | Open, Classified |
| Reason | Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). |
| 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 Cus |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 Carefusion 303, Inc., Jul 21, 2023 |