Baxter Healthcare Corporation Recall 90643
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.
Baxter Healthcare Corporation Recall 90643 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1570-2022 |
| Event ID | 90643 |
| Event 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. |
| Product Type | Devices |
| 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 Arab Emirates. |
| Quantity | 448,960 units |
| Recall Reason | There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets. |
| Device Classification | 20220831 |
| Device Code Info | Product Code: H938724 Lot Number 60316024 and higher; expiry beginning with 04/30/2024 UDI/GTIN: 00085412477183 |
| Center Classification Date | 20220824 |
| Recall Initiation Date | 20220714 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
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