FDA Device recall Z-1570-2022
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to comp…
- FDA Device
- Class II
- ongoing
- Published 2022-08-31
On 2022-08-31 the FDA classified a Class II recall of The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to comp… by Baxter Healthcare, citing there is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1570-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-14 |
| Published | 2022-08-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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.
Reason
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
Identifiers
| code_info | Product Code: H938724 Lot Number 60316024 and higher; expiry beginning with 04/30/2024 UDI/GTIN: 00085412477183 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1570-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.