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 | Ongoing |
| Reason | MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the MiniCap, which could lead to the potential for inadequate disinfectant. |
| Product | Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis |
| Quantity | 33,866,400 units |
| Distribution | US Nationwide distribution and Canada. |
| Initiated | 2023-02-01 |
| Classified | 2023-03-03 |
| Recall number | Z-1213-2023 |
| 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-1213-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91612/
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