BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
This recall is currently active, issued August 30, 2024. It was issued by Carefusion 303, Inc..
- Company
- Carefusion 303, Inc.
- Recall Initiated
- July 9, 2024
- Posted
- August 30, 2024
- Recall Number
- Z-2948-2024
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of CA, FL, KS, MN, NJ, NY, PA.
Lot / Code Info
serial numbers: 16056243 16068264 16082950 16142772 16192674 16208218 16208219 16284106 16346254 16388826 16388833 16623139 / UDI: None
Root Cause
Software design
Action Taken
On July 11, 2024, CareFusion a subsidiary of Becton Dickinson (BD) issued a "Urgent Medical Device Correction" Notification to affected customers via Email. BD also notified customers through customer software release notes beginning June 24, 2024. BD asked consignees to take the following actions: 1. When restocking the cabinet, refer to the MedBank restock workflow screen to verify the correct bin location rather than the printed label until the software update is provided. 2. Users should verify the contents of the bin location being restocked. Actions to be Taken by the Customer: 3.Please circulate this notice to all those who require awareness within your organization or to any organization whom you may have transferred BD Pyxis" MedBank" CUBIE" Replenishment Station devices to. 4.Please promptly complete and return the enclosed Customer Response Form within 15 days to acknowledge receipt of this notification and that you understand the information provided in this letter. 5. BD will perform remote upgrades to impacted customer devices with the updated CR/QFill station software. BD will contact customers by the end of August to initiate this scheduling.