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.
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation is recalling the Exacta-Mix 2400 compounding system due to a potential for leaking valves on ports 1 to 4 in certain lots of valve sets. The affected product code is H938724 with lot numbers 60316024 and higher, with expiry dates beginning 04/30/2024. Approximately 448,960 units have been distributed worldwide, including throughout the United States, Canada, and numerous countries in Europe, the Middle East, Asia, and Latin America.
The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
Reason for recall: There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets. 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 Ara Quantity: 448,960 units Lot/code info: Product Code: H938724 Lot Number 60316024 and higher; expiry beginning with 04/30/2024 UDI/GTIN: 00085412477183
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.