—#212552

Product

BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software

FDA product code: PHC — Infusion Safety Management Software
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K211218
Affected lot / code info: Software: v1.7.2/UDI: 10885403510472

Why it was recalled

Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None

Timeline

Recall initiated: 2025-02-18
Posted by FDA: 2025-03-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212552. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.