Z-1570-2022 Class II Ongoing
FDA device recall Z-1570-2022 was initiated by Baxter Healthcare Corporation on Jul 14, 2022 and is designated Class II. Reason for recall: There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets. The recall status is ongoing. Affected quantity: 448,960 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 31, 2022
- Initiation Date
- Jul 14, 2022
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1570-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026