Recalls / —

—#216046

Product

Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00

FDA product code

BRY — Cabinet, Table And Tray, Anesthesia

Device class

Class 1

Medical specialty

Anesthesiology

Affected lot / code info

All Serial Numbers/Ref #/UDI: 1149-00 10885403517822 and 1152-00 10885403517839

Why it was recalled

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On 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.

Recalling firm

Firm

CareFusion 303, Inc.

Address

10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.

Timeline

Recall initiated

2025-09-30

Posted by FDA

2025-10-27

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #216046. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.