BD Alaris Point-Of-Care Units Recalled Over Network Connectivity and System Error Risks

What Happened

Becton Dickinson (BD) is issuing a voluntary product communication regarding its Alaris and BD Alaris Point-of-Care Units (PCU). The recall was initiated because the product labeling does not specify which Transport Layer Security (TLS) versions must be enabled on hospital networks to ensure secure Wi-Fi communication.

Currently, Alaris and BD Alaris PCUs (version 12.1.3 and prior) are only compatible with TLS 1.0. If a hospital network disables TLS 1.0, the units will fail to connect to the wireless network. This failure can lead to interoperability issues requiring manual programming. Furthermore, if TLS 1.0 is disabled during use, the units may experience a memory leak following authentication failure. This leak consumes available memory over time and can lead to a system error, which may occur during active infusions.

Which Products Are Affected

The recall affects the following medical devices:

• Product Name: Alaris & BD Alaris Point-Of-Care Unit (PCU)
• Model Number: 8015
• Software Versions: v12.1.3 and prior
• Serial Numbers: More than 10 serial numbers are affected; consumers are advised to contact the manufacturer for specific details.
• Manufacturer: Carefusion 303, Inc., based in San Diego, California.

What You Should Do

Healthcare facilities using these devices should ensure that TLS 1.0 remains enabled on their hospital networks to maintain secure Wi-Fi communication and prevent system errors. For facilities utilizing bi-directional workflows, be aware that network failures will require users to manually program the devices.

For additional information or to verify affected serial numbers, contact Carefusion 303, Inc. at 10020 Pacific Mesa Blvd., San Diego, California, 92121.

Why This Matters

A system error occurring during an active infusion poses a significant risk to patient safety, as it can disrupt the delivery of critical medications or fluids. Ensuring network compatibility is essential to preventing device malfunction in clinical settings.

Source

Health Canada