BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet
Recall
- Recall Number
- Z-1928-2024
- Event Number
- 94527
- Firm
- CareFusion 303, Inc.
- FEI Number
- 2016493
- Product Code
- BRY
- Status
- Open, Classified
- Root Cause
- Component design/selection
- Initiated
- April 15, 2024
- Posted
- May 30, 2024
- Address
- 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386
Description
BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
On May 2, 2024, CareFusion, a subsidiary of Becton, Dickinson and company issued a "Urgent Medical Device Correction", to affected consignees. 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.
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of South Africa, Kuwait, Qatar, Singapore, Bermuda, United Arab Emirates, Argentina, Australia, Belgium, Bahrain, Brazil, Bahamas, Canada, Chile, China, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Italy, Japan, South Korea, Lebanon, Morocco, Mexico, New Zealand, Oman, Portugal, Thailand, Taiwan.
91,933 units