FDA Enforcement
Class II
Ongoing
BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Recall: Z-2948-2024
·
Reported September 11, 2024
Enforcement
- Recall Number
- Z-2948-2024
- Event ID
- 95070
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- CareFusion 303, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- September 11, 2024
- Initiation Date
- July 9, 2024
- Classification Date
- August 30, 2024
- Address
- 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States
Description
BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Reason
Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
Code Info
serial numbers: 16056243 16068264 16082950 16142772 16192674 16208218 16208219 16284106 16346254 16388826 16388833 16623139 / UDI: None
Distribution
US Nationwide distribution in the states of CA, FL, KS, MN, NJ, NY, PA.