BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
FDA device recall Z-1305-2025 · posted 2025-03-13 · Open, Classified
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- PHC
- 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
- Date initiated
- 2025-02-18
- Date posted
- 2025-03-13
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD Alaris System with Guardrails Suite MX v12.1.2 (K211218) | Carefusion 303, Inc. | 2023-07-21 |