BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

Recall Insight

This FDA Devices action (record #Z-1304-2025) was formally reported on March 19, 2025, with the manufacturer initiating the action on February 18, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. CareFusion 303, Inc. is listed as the recalling firm, operating out of San Diego, CA. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.

The documented reason for this recall is: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). Distribution data in the federal record shows the product reached: US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.