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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-1120-2025
Recall Event ID 96056
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;
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; ALL serial numbers; software versions v1.10 and prior
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		Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
FDA Determined
Cause 2		Labeling design
ActionOn January 8, 2025, the firm notified customers through an "Urgent Medical Device Correction" letter sent via email and mailed notices. In addition to explaining software issues affecting the device (covered in RES 96055), the letter also provided customers with a list of mitigations that address device downtime as a result of power failure, network failure, or hardware failure. The firm will be updating product labeling and product guides to further strengthen recommendations.
Quantity in Commerce137478
DistributionDomestic distribution nationwide US. 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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