Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
Summary
The FDA issued a Class II for Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 a by CareFusion 303, Inc.. Reason: Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire..
Details
Source
Device Recall
External ID
Z-0369-2026
Action Date
2025-11-05
Status
Ongoing
Category
device
Product Description
Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
Lot/Code Info: All Serial Numbers/Ref #/UDI: 1149-00 10885403517822 and 1152-00 10885403517839
Quantity Affected: 32 units
Reason for Recall
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-30
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 284 device recalls issued in the same week, part of 413 device-related FDA actions this month.
CareFusion 303, Inc. has 105 FDA actions in our database, including 103 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CareFusion 303, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CareFusion 303, Inc. have FDA actions?
CareFusion 303, Inc. has 105 FDA actions in our database, including 103 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0369-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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