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 | Terminated |
| Reason | Leakage from the inlet port of the 15L Cycler Drainage Bags. |
| Product | Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path |
| Quantity | 19,440 units |
| Distribution | US Distribution and Internationally to Canada. |
| Initiated | 2015-10-06 |
| Classified | 2015-10-30 |
| Terminated | 2016-06-27 |
| Recall number | Z-0194-2016 |
| 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-0194-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72362/
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