FDAClass IMarch 19, 2025

BD Alaris Systems Manager recall: Software Issue

BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

Why was BD Alaris Systems Manager recalled?

Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

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?

Software v12.5.1 or v12.5.2, and prior versions (4.33, 12.0.1, 12.0.2, 12.1, 12.1.2, 12.3) UDIs: 10885403960123 10885403519666 (10885403960116)

Product
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Recalling firm
CareFusion 303, Inc.
Distribution
US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None
Recall date
March 19, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls