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U.S. Department of Health and Human Services

Class 2 Device Recall BKIT BD Pyxis QFill Replenishment Station

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 Class 2 Device Recall BKIT BD Pyxis QFill Replenishment Stationsee related information
Date Initiated by FirmJuly 09, 2024
Date PostedAugust 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2948-2024
Recall Event ID 95070
Product Classification Cabinet, table and tray, anesthesia - Product Code BRY
ProductBKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Code Information serial numbers: 16056243 16068264 16082950 16142772 16192674 16208218 16208219 16284106 16346254 16388826 16388833 16623139 / UDI: None
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information ContactTechnical Support
1866-930-9251
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 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.
DistributionUS Nationwide distribution in the states of CA, FL, KS, MN, NJ, NY, PA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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