CME America, LLC recalls BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The Bo…
- Recall date
- September 16, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1442-2020
- FDA classification
- Class I
- Brand / firm
- CME America, LLC
- Sold / distributed
- US: CA, OH, PA, and TX OUS: Canada
Why it was recalled
When using a specific tubing set with infusion pump system, may result in under deliver of fluids.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.
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