CareFusion 303 recalled 1,025,567 units of the BD Alaris System with Guardrails Suite MX with Point of Care Unit worldwide. The recall concerns labeling that fails to indicate which TLS version must be enabled for secure hospital Wi-Fi communication. Hospitals and clinicians should stop using the device immediately and follow manufacturer instructions. The recall was issued by the FDA and is being
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
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact CareFusion 303, Inc. or your healthcare provider for instructions. Notification method: Letter
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The BD Alaris System with Guardrails Suite MX with Point-of-Care Unit is a hospital infusion pump system used to administer IV medications. It integrates with hospital networks and Wi-Fi for remote monitoring and control.
The recall concerns labeling that does not indicate which TLS version must be enabled for secure Wi-Fi communication with Point-of-Care Units, potentially compromising network security.
This recall is not described as part of a broader industry pattern in the notice.
Hospitals may experience delays or risk if TLS requirements are not configured correctly, potentially affecting device communication with clinical staff and patient safety.
Look at the device label, packaging, and the manufacturer recall notice for Catalog Number 8015, UDI-DI, and Serial Numbers.
Not specified in the recall notice. Expect guidance from the manufacturer and FDA on a remediation timeline.
Keep a copy of the recall notice, maintain a log of serial numbers checked, and photograph device labeling for records.
Catalog Number: 8015. UDI-DI codes include 10885403210747, 10885403210754, 10885403210891, 10885403212048, 10885403222108, 10885403224614, 10885403515231, 10885403516023, 10885403519215, 10885403519284, 10885403519291, 10885403801518, 10885403801532, 10885403801549. Serial Numbers include a long list beginning with 12360968, 12360983, 12360985, 12360986, 12360987, 12360988, 12360989, 12360990, 12360991, 12360992, 12360993, 12360994, 12360995, 12360996, 12360997, 12360998, 12360999, 12361000, 12361001, 12361002. Discontinued or distributed worldwide. Sold through hospitals and healthcare system
No injuries or incidents have been reported.
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