CareFusion Alaris System recall: Software Issue
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
Why was CareFusion Alaris System recalled?
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
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?
Model 8000, software versions 9.5 and prior; Model 8015, software versions 12.1.0, and 9.33 and prior
- Product
- CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 870070
- Distribution
- Worldwide Distribution: (U.S. Nationwide) to states of: CO, SC, NY, CA, LA, TX, AK, ID, VA, DE, FL, PA, KY, KS, TN, WA, MS, IL, GA, AR, NC, NV, NE, OR, RI, WI, HI, GU, PR, MA, IA, CT, MI, AZ, ME, MT, IN, OH, WV, WY, MN, AL, NH, OK, DC, NJ, MO, SD, UT, NM, MD, VT, MP, ND, AS; and countries of: Canada, Australia, New Zealand, the Middle East, South Africa, Taiwan, Southeast Asia and the European Union.
- Recall date
- March 11, 2020
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)