Class II — Baxter Healthcare Corporation
| Recalling firm | BAXTER HEALTHCARE CORPORATION |
|---|---|
| Registered facility | View this company's 32 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Devices distributed lacked regulatory clearance. |
| Product | MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484 |
| Quantity | 498 units |
| Distribution | US Nationwide distribution in the states of California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Louisiana, Michigan, Missouri, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, and Texas. |
| Initiated | 2022-02-25 |
| Classified | 2022-03-29 |
| Terminated | 2026-05-15 |
| Recall number | Z-0831-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Baxter Healthcare Corporation (Z-0831-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89521/
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