FDA Recall Open, Classified

BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system

Recall: Z-2947-2024 · Initiated July 9, 2024

Recall

Recall Number
Z-2947-2024
Event Number
95070
Firm
CareFusion 303, Inc.
FEI Number
2016493
Product Code
BRY
Status
Open, Classified
Root Cause
Software design
Initiated
July 9, 2024
Posted
August 30, 2024
Address
10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

Description

BD Pyxis QFill Replenishment Station, REF: 138904-01, 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.

Action

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.

Distribution

US Nationwide distribution in the states of CA, FL, KS, MN, NJ, NY, PA.

Quantity

3 units