BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
- Company
- Carefusion 303, Inc.
- Recall Initiated
- February 18, 2025
- Posted
- March 13, 2025
- Recall Number
- Z-1305-2025
- Firm Location
- San Diego, CA
Reason for Recall
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
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
Lot / Code Info
Software: v1.7.2/UDI: 10885403510472
Root Cause
Under Investigation by firm
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.