—#216289

Product

BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K211218
Affected lot / code info: All Alaris Pump Modules distributed after June 19, 2004. REF/UDI-DI: 8100/10885403810015, 10885403810046, 10885403810039, 10885403222054, 10885403517723, 10885403213212, 10885403211423; 49000437/10885403471018; 49000270/10885403247743

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: Worldwide distribution. US nationwide including Puerto Rico, Guam, American Samoa, Northern Mariana Islands; and countries of SG, BH, AE, JP, CA, IT, QA, PH, DE, TW, PK, KR, BW, SA, MY, IL, NZ, AU, IN, GB, CN, NL, FR, ZA, BE, MX, CH, GI, KW, and TR.

Timeline

Recall initiated: 2025-10-17
Posted by FDA: 2025-11-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216289. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.