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U.S. Department of Health and Human Services

Class 2 Device Recall BD Pyxis

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 Class 2 Device Recall BD Pyxissee related information
Date Initiated by FirmJanuary 08, 2025
Date PostedFebruary 07, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1119-2025
Recall Event ID 96055
Product Classification Cabinet, table and tray, anesthesia - Product Code BRY
Product(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
Code Information (1) Pyxis MedStation ES, Catalog No. 323, UDI-DI 10885403512667; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327, UDI-DI 10885403477836; (3) Pyxis MedStation ES Tower, Catalog No. 352, UDI-DI 10885403512674; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00, UDI-DI 10885403512605; All Serial Numbers; Software Versions v1.10 and prior Affected
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information ContactCustomer Letter Support
800-727-6102
Manufacturer Reason
for Recall		Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
FDA Determined
Cause 2		Software design
ActionOn January 8, 2025, the firm notified customers via email and mailed letter titled "Urgent Medical Device Correction". Firm states customers can continue to use Pyxis products in accordance with their labeling and any previously provided field action notifications, including the following guidance: 1. Facilities should establish policies and procedures for when an automated dispensing system is unavailable. 2. Device Keys can manually access unavailable drawers, but must be readily available and retrievable to adequately mitigate the risk. 3. Emergency supplies should be physically available in care areas for critical or urgent medications. 4. If using critical override mode to access contents of the device, users must use extra precautions and verify correct medications are selected. The firm anticipates releasing software update ES 1.11 beginning June 2025, which will address these software issues.
Quantity in Commerce137,741 total
DistributionDomestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia.
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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