FDAFDA · Food and drugs·Recall number Z-1570-2022
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.
Published August 31, 2022 · Recall initiated: July 14, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- 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.
- Lot
- Product Code: H938724 Lot Number 60316024 and higher; expiry beginning with 04/30/2024 UDI/GTIN: 00085412477183
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.