Z-2179-2025 Class I Ongoing
FDA device recall Z-2179-2025 was initiated by CareFusion 303, Inc. on July 8, 2025 and is designated Class I. 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,… The recall status is ongoing. Affected quantity: 33,162,680 units total.
Recall Details
- Product Type
- Devices
- Report Date
- August 13, 2025
- Initiation Date
- July 8, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,162,680 units total
Product Description
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
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 Pattern
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
Code Information
BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046