FDA Enforcement
Class II
Ongoing
All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
Recall: Z-0371-2026
·
Reported November 5, 2025
Enforcement
- Recall Number
- Z-0371-2026
- Event ID
- 97566
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- CareFusion 303, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 5, 2025
- Initiation Date
- September 30, 2025
- Classification Date
- October 27, 2025
- Address
- 10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States
Description
All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
Reason
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Code Info
Ref #/UDI: 1116-00 10885403512605
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
Quantity
443 units