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 | Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions. |
| Product | SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids. |
| Quantity | 273,835 units |
| Distribution | Worldwide Distribution-USA including Puerto Rico and Canada. |
| Initiated | 2013-06-10 |
| Classified | 2013-11-08 |
| Terminated | 2017-04-20 |
| Recall number | Z-0197-2014 |
| 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-0197-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66120/
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