FDA DeviceClass IINotable

FDA Recall: BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

Date: 2026-04-01
Brand: CareFusion 303, Inc.
Category: Medical Device
FDA Class: Class II

Description

Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

Hazard

Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

Remedy

1,025,567

Related Recalls

FDA Recall: BD Alaris" System with Guardrails" Suite MX with Point of Care Unit | WatchRecall