CareFusion 303, Inc. recalls Various models of BD Pyxis Pro 7-Drawer Auxiliary
Reason for recall
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and1152-00UDI 1149-004 affected lots1149-00108854035178221152-0010885403517839
What the firm is doing
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.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0369-2026
- FDA device classification · BRYOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.6100The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find CareFusion 303, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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