Baxter Recalls SIGMA SPECTRUM Infusion Pump LCD Screens for Discharge Failure
Baxter Healthcare is recalling 346 SIGMA SPECTRUM Infusion Pump LCD screens that failed to withstand electrostatic discharge.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a component failure (electrostatic discharge) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a medical device defect.
Plain-English summary
Baxter Healthcare Corporation is recalling the LCD display screen component for the SIGMA SPECTRUM Infusion Pump with Master Drug Library. The specific component is the SHARP LCD screen, part number 55074-2 revision B. The recall involves 346 units.
The recall was initiated because the LCD display screens did not meet standards for withstanding an electrostatic discharge. These infusion pumps are intended to be used as a visual aid during the controlled administration of intravenous fluids, which may include pharmaceutical drugs, blood, blood products, and mixtures of required patient therapy.
The affected units were distributed worldwide, including nationwide in the United States 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, as well as in Canada. Users should identify affected units by checking for Product Codes 35700BAX and 35700ABB and the specific serial numbers listed in the official recall notice.
The recalled product
- 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 pr
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Infusion Pump
- Affected units
- 346
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code: 35700BAX & 35700ABB
- Serial Numbers: 433713
- 435563
- 704056
- 707290
- 715315
- 724216
- 740127
- 752318
- 752447
- 753675
- 754947
- 759766
- 765934
- 770034
- 772017
- 773470
- 776507
- 781016
- 781969
Distribution
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