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U.S. Department of Health and Human Services

Class 2 Device Recall BD Pyxis CII Safe ES Tower Main

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 Class 2 Device Recall BD Pyxis CII Safe ES Tower Mainsee related information
Date Initiated by FirmSeptember 30, 2025
Date PostedOctober 27, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0371-2026
Recall Event ID 97566
Product Classification Cabinet, table and tray, anesthesia - Product Code BRY
ProductAll Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
Code Information Ref #/UDI: 1116-00 10885403512605
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information ContactBD Technical Support
1800-727-6102
Manufacturer Reason
for Recall		Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn September 30, 2025, BD issue a Urgent Medical Device Recall Expansion notification to affected consignees via FedEx. BD is asking consignees to take the following actions: 1. Affected products can continue to be used per existing Manuals and Guides. 2. In the event of an accidental fluid spill on the device or in a drawer, users should following instructions outlined within the customer notification. 3. Review the customer letter attachment which provides warnings, cautions and recommendations regarding fluid ingress. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material.
Quantity in Commerce443 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
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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