BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system

FDA device recall Z-2948-2024 · posted 2024-08-30 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

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.

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.

Root cause

Software design

Status

Open, Classified

Product code

BRY

Distribution

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

Date initiated

2024-07-09

Date posted

2024-08-30

Location

San Diego, CA