Z-0430-2026Class I

BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE...

Name: Z-0430-2026 BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE...
Creator: CareFusion 303, Inc.
Published: 2025-10-17
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2025-10-17 / Open, Classified / root cause: design

FDA source

CareFusion 303, Inc. began a recall of 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... on 2025-10-17. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0430-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-10-17
Posted: 2025-11-20
Recalling firm: CareFusion 303, Inc
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
Product code: FRN Pump, Infusion
Reason for recall: 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 tag: design
FDA root cause: Device Design
Action: 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 [email protected] 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, [email protected] . Product Complaints: [email protected] 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.
Quantity in commerce: 2,574,396
Distribution: 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.
Product codes and lots: All Alaris Pump Modules distributed after June 19, 2004. REF/UDI-DI: 8100/10885403810015, 10885403810046, 10885403810039, 10885403222054, 10885403517723, 10885403213212, 10885403211423; 49000437/10885403471018; 49000270/10885403247743

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0430-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0430-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-20

Product code FRN

K211218Class IIBD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. / cleared 2023-07-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)