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 is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Master Drug Library for not meeting standards for withstanding an electrostatic discharge. |
| Product | SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. |
| Quantity | 346 units |
| Distribution | Worldwide Distribution - USA Nationwide in the states of: AR, AZ, CA, CO, CT, FL, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NY, OH, OK, OR, PA, TN, UT, VA, WA and WV and the country Canada. |
| Initiated | 2013-09-24 |
| Classified | 2013-11-08 |
| Terminated | 2016-11-09 |
| Recall number | Z-0189-2014 |
| 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-0189-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66392/
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