CareFusion 303, Inc. recalls BD Alaris infusion Pump Module 8100

If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.

On 10/17/2025, correction notices were mailed and emailed: Distribute notice to clinical and non-clinical users. Safety Reminder: https://academy.bd.com/en-us/home. Provide notice to any facilities you may have sold or transferred devices to. Use only BD-authorized companies when renting infusion devices. Complete and return response form to bdrc55@bd.com If dropped, biomedical engineering should perform testing as specified in Level of Testing Guidelines, including rate accuracy verification testing. If any test fails see troubleshooting section, see Technical Service Manual, Chapter 5 and 6. User Manuals: https://bd.com/self-service. Firm contacts: Technical Support 888-812-3229, DL-US-INF-TechSupport@bd.com . Product Complaints: ProductComplaints@bd.com BD Alaris Infusion System Safety Reminder: To ensure system remains in good operating condition, if a device or accessory is dropped or severely jarred, take the device out of use. Even if no visible damage is present, internal components may be affected. Return the device to Biomedical Engineering for inspection and repair. Visually inspect the system before each use. Check all visible surfaces and moving parts and if you observe damage or find the device does not function as expected, return it to biomedical engineering for repair. Do not use a device that appears to be damaged or does not function as expected. Return device to Biomedical Engineering for repair. Only biomedical engineering should perform annual maintenance as specified in the System Maintenance Software User Manual. Important in ensuring regular testing of any potentially dropped or damaged device that was not immediately removed from use to prevent infusion errors, protect patient safety, and promote proper function. All should understand the potential safety risks associated with using a device that may have sustained damage.

• FDA enforcement recordOfficial FDA database entry for Z-0430-2026
• FDA 510(k) clearance · K211218The device's official FDA premarket clearance record
• FDA device classification · FRNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5725The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find CareFusion 303, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.