Class II — Baxter Healthcare Corp.
| 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 | Completed |
| Reason | Product may have separating or protruding sponges |
| Product | MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis. |
| Quantity | 4,391,520 units |
| Distribution | Worldwide Distribution - Nationwide Distribution and to the countries of : Canada, Austria, Norway, Portugal, Saudi Arabia and Spain. |
| Initiated | 2015-01-22 |
| Classified | 2015-03-13 |
| Recall number | Z-1269-2015 |
| 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 Corp. (Z-1269-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70512/
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