BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Summary
The FDA issued a Class I for BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions by CareFusion 303, Inc.. Reason: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy.
Details
Source
Device Recall
External ID
Z-2179-2025
Action Date
2025-08-13
Status
Ongoing
Category
device
Product Description
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Lot/Code Info: BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046
Quantity Affected: 33,162,680 units total
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-08
Company
San Diego, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 172 device recalls issued in the same week, part of 413 device-related FDA actions this month.
CareFusion 303, Inc. has 105 FDA actions in our database, including 103 recalls and 2 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CareFusion 303, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CareFusion 303, Inc. have FDA actions?
CareFusion 303, Inc. has 105 FDA actions in our database, including 103 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2179-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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