FDA Enforcement
Class II
Ongoing
BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9
Recall: Z-2503-2024
·
Reported August 14, 2024
Enforcement
- Recall Number
- Z-2503-2024
- 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 MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 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: 16210468 16274000 16232272 16209954 16209953 16097230 16184767 16101319 16095341 16112043 15815836 15631124 15632972 15937573 16073534 16173241
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
16 units