FDA-Device2025-02-05Class II
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized healthcare provider.
CareFusion 303, Inc.
Hazard
Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication.
Sold states
U.S.: AK, AL, AR, 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, and WY. O.U.S.: Germany and Japan
Affected count
Initial: 27,666 Expansion: 5,923 = 33,589 systems
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1050-2025Don't want to check this manually?
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