Medical device recalls High risk

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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