All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
- Company
- Carefusion 303, Inc.
- Recall Initiated
- September 30, 2025
- Posted
- October 27, 2025
- Recall Number
- Z-0371-2026
- Quantity
- 443 units
- Firm Location
- San Diego, CA
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.
Lot / Code Info
Ref #/UDI: 1116-00 10885403512605
Root Cause
Under Investigation by firm
Action Taken
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.