FDA-Device2022-08-31Class II
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.
Baxter Healthcare Corporation
Hazard
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
Sold states
Worldwide distribution: US Nationwide, Canada, Uruguay, Argentina, Brazil, Colombia, Dominican Republic, Panama, Puerto Rico, Hong Kong, Taiwan, Korea, United Kingdom, Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Kuwait, Netherlands, Oman, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates.
Affected count
448,960 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1570-2022Don't want to check this manually?
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