FDAFDA · Food and drugs·Recall number Z-2262-2024
BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
Published July 10, 2024 · Recall initiated: May 21, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CareFusion 303, Inc.
- Distributor
- 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.
- Lot
- UDI: 10885403960123/ Software versions 12.5.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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