BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
Summary
The FDA issued a Class I for BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software by CareFusion 303, Inc.. Reason: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU)..
Details
Source
Device Recall
External ID
Z-1305-2025
Action Date
2025-03-19
Status
Ongoing
Category
device
Product Description
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
Lot/Code Info: Software: v1.7.2/UDI: 10885403510472
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Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-18
Company
San Diego, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 159 device recalls issued in the same week, part of 413 device-related FDA actions this month.
CareFusion 303, Inc. has 105 FDA actions in our database, including 103 recalls and 2 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CareFusion 303, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CareFusion 303, Inc. have FDA actions?
CareFusion 303, Inc. has 105 FDA actions in our database, including 103 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1305-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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