Recall Z-1217-2026 ยท FRN Pump, Infusion
CareFusion 303, Inc.
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 fl
| Date | Jan 29, 2026 (initiated Nov 6, 2025) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | 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 Alari |
| Quantity | 189 devices |
| Distribution | U.S. Nationwide distribution in the states of AZ, IN, OH, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 Carefusion 303, Inc., Jul 21, 2023 |