4 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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BD Alaris PCU REF 8015
FDA Enforcement
Class I
·Ongoing·CareFusion 303, Inc.·November 15, 2023
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
FDA Enforcement
Class I
·Ongoing·CareFusion 303, Inc.·March 19, 2025
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
FDA Enforcement
Class I
·Ongoing·CareFusion 303, Inc.·March 19, 2025
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.
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·February 4, 2026