Device product
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.
Z-1570-2022
Product summary
- Event
- Event 90643
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 448,960 units
- Official record key
device-enforcement:Z-1570-2022
Official wording
Reason: There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
Code information: Product Code: H938724 Lot Number 60316024 and higher; expiry beginning with 04/30/2024 UDI/GTIN: 00085412477183
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.
Derived failure modes
-
Unknown
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.