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.
Reported: August 31, 2022 Initiated: July 14, 2022 #Z-1570-2022
Product Description
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.
Reason for Recall
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 448,960 units
- Distribution
- 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.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Baxter Healthcare Corporation. Units affected: 448,960 units.
Why was this product recalled? ▼
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2022. Severity: Moderate. Recall number: Z-1570-2022.
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