Z-1570-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2022
- Initiation Date
- July 14, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 448,960 units
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.
Distribution Pattern
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.
Code Information
Product Code: H938724 Lot Number 60316024 and higher; expiry beginning with 04/30/2024 UDI/GTIN: 00085412477183