Z-2179-2025Class I

BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions

Name: Z-2179-2025 BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Creator: CareFusion 303, Inc.
Published: 2025-07-08
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2025-07-08 / Open, Classified

FDA source

CareFusion 303, Inc. began a recall of BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions on 2025-07-08. FDA classified it as Class I and gives the reason as "Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2179-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-07-08
Posted: 2025-08-06
Recalling firm: CareFusion 303, Inc
Product: BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Product code: FRN Pump, Infusion
Reason for recall: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
FDA root cause: Under Investigation by firm
Action: On December 12, 2025, CareFusion 303, Inc. (BD) issued a updated "Urgent Medical device Recall Notice via E-Mail and physical mail. The updated notice includes important information on infusion sets as well as labeling updates. Previous notifications were sent on July 8,2025, July 17, 2025, September 11, 2025 and September 12, 2025. CareFusion ask consignees to take the following actions: 1. Review your inventory for the catalog numbers included in the updated letter. Remove and discard any remaining inventory per your facility guidelines. 2.To receive credit or replacement product, please return the completed customer response form attached to this notice. 3.Please contact your BD Clinical Consultants and Account Executives for alternative sets information. 4. Review the updated sets performance data included in the letter. 5. Circulate this notice within your facility network to ensure that all concerned personnel are made aware of this issue. 6. Distributors should provide a copy of this notice to all customers who may have purchased an Alaris Pump Module. If you require further assistance, please contact: BD Technical Support at Phone: 888-812-3229; Phone hours: 6:00am to 5:00pm PT Monday Friday and Email: [email protected].
Quantity in commerce: 33,162,680 units total
Distribution: US Nationwide Distribution to states of: AK AL AR AS AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MP MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY; and OUS (foreign) to countries of: Japan, Italy, Germany, Turkey
Product codes and lots: BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2179-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2179-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-06
Z-2180-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-06

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)