Skip to content
Recall Observatory FDA recall evidence

Device product

BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9

Z-2499-2024

June 24, 2024

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 94947
Status
Ongoing
Classification
Class II
Quantity
12 units
Official record key
device-enforcement:Z-2499-2024

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: 16073532 16068549 15940102 15815823 15854750 15422135 15879981 15639689 15935614 15937588 16083491 16087005

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