FDA Enforcement Class II Ongoing

BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9

Recall: Z-2487-2024 · Reported August 14, 2024

Enforcement

Recall Number
Z-2487-2024
Event ID
94947
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
CareFusion 303, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
August 14, 2024
Initiation Date
June 24, 2024
Classification Date
August 2, 2024
Address
10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

Description

BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9

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 Info

UDI: 10885403512568/ Serial Number: 16139674 16124908 16063924 16084467 16221549 16139675 16220875 16237258 16284001 15940400 15940104 15941703 15941654 15943750 15943749 15500696 15654711 15654721 15631099 15631104 15775749 15383480 15383481 15383475 15383486 15383487 15366328 15606170 15575974 15575976 15490745 15422133 15853047 15902413 15598095 15550853 15437809 15437812 15518269 15518273 15518270 15872432 15872429 15662816 15504833 15504836 15503511 15430948 15430963 15639687 15639724 15639720 15639718 15328493 15442794 15442789 15761398 15761401 15937579 15786154 15684803

Distribution

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.

Quantity

61 units