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Recall Observatory FDA recall evidence

Device product

BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9

Z-2503-2024

June 24, 2024

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 94947
Status
Ongoing
Classification
Class II
Quantity
16 units
Official record key
device-enforcement:Z-2503-2024

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: 16210468 16274000 16232272 16209954 16209953 16097230 16184767 16101319 16095341 16112043 15815836 15631124 15632972 15937573 16073534 16173241

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