BD Alaris Pump Module recall
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Why was BD Alaris Pump Module recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046
- Product
- BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 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
- Recall date
- August 13, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)