FDA Enforcement
Class II
Ongoing
BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9
Recall: Z-2488-2024
·
Reported August 14, 2024
Enforcement
- Recall Number
- Z-2488-2024
- 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-10HH-2FH-P, REF: 169-82 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: 15806714 15949551 16043223 16194366 16122742 16111668 15940148 15931010 15930743 15943757 16203044
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
11 units