BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.
Recall
- Recall Number
- Z-1217-2026
- Event Number
- 97871
- Firm
- CareFusion 303, Inc.
- FEI Number
- 2016493
- Product Code
- FRN
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- November 6, 2025
- Posted
- January 29, 2026
- Address
- 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386
Description
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.
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: [email protected]
U.S. Nationwide distribution in the states of AZ, IN, OH, and VA.
189 devices