FDAClass IIJuly 10, 2024

BD Alaris System Manager recall: Software Issue

BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units

Why was BD Alaris System Manager recalled?

Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.

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?

UDI: 10885403960123/ Software versions 12.5.1

Product
BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
Recalling firm
CareFusion 303, Inc.
Quantity
168 software version
Distribution
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI.
Recall date
July 10, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls