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Recall Observatory FDA recall evidence

Device product

BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9

Z-2489-2024

June 24, 2024

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 94947
Status
Ongoing
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-2489-2024

Official wording

Reason: Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

Code information: UDI: 10885403512568/ Serial Number: 16210460 16191229 16227391 16260053 16055232 16102551

Distribution pattern: US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issue