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FDA Medical Device Recalls (openFDA)

CareFusion 303, Inc.: BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system

Recall number
Z-2947-2024
Recalling firm
CareFusion 303, Inc.
Product
BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
Status
Open, Classified
Initiated
2024-07-09
Posted
2024-08-30
Terminated
not on file
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.
Root cause
Software design
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.
Quantity
3 units
Distribution
US Nationwide distribution in the states of CA, FL, KS, MN, NJ, NY, PA.
Lot, serial or model codes
serial numbers: 44210411, 43880801, 44227426/ UDI: None
510(k) numbers
not on file
PMA numbers
not on file
Product code
BRY
Firm FEI
2016493
Firm city
San Diego
Firm state
CA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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