CareFusion 303, Inc. recalls BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM Syste…

Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network

On 11/06/2025, the firm sent via mail and email an "URGENT MEDICAL DEVICE PRODUCT CORRECTION" Letter informing customers that during an electronic medical record interoperability workflow, a BD Alaris" PCU (Point of Care Unit) connected to an affected BD Alaris" Pump Module may disconnect from the hospital network. The connectivity issue relates to an unrecognized date and time ( datetime ) stored within the affected BD Alaris" Pump Module software. The software that was loaded onto the affected pump modules has a datetime that falls within the Daylight Savings Time (DST) adjustment. The Alaris" System Manager software that mediates connectivity between the PCU module and the hospital network does not recognize this DST datetime as valid, resulting in loss of connectivity between the PCU module and the network. Instructions to Clinicians: 1. If an affected Pump Module is being used in bi-directional interoperative workflows, return it to Biomedical Engineering when clinically feasible. 2. No immediate action is required if the facility does not utilize bi-directional interoperative workflows. In such cases, the affected Pump Module should be returned to Biomedical Engineering when not in use. Instructions for Customers and Distributors: 1. Locate the affected devices identified in Attachment A and return to Biomedical Engineering for re-flashing. 2. Complete the attached Customer Response Form and return it to the BD contact noted on the form so that BD may acknowledge your receipt of this notification. 3. Please contact the BD Recall Support Center to coordinate self-remediation or depot-based remediation. If performing self-remediation, the Support Center will provide a tracking form to document completion back to BD. Alternatively, customers may return their affected devices to be serviced by the BD Service Center. For Questions - contact Recall Support Center Phone: 1-888-562-6018 Phone Hours: 7:00am to 4:00pm PT, Monday- Friday Email: SupportCenter@bd.com

• FDA enforcement recordOfficial FDA database entry for Z-1217-2026
• FDA 510(k) clearance · K211218The device's official FDA premarket clearance record
• FDA device classification · FRNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5725The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find CareFusion 303, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.