FDA-Device2020-03-18Class I

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.

CME America, LLC
Hazard

When using a specific tubing set with infusion pump system, may result in under deliver of fluids.

Sold states
US: CA, OH, PA, and TX OUS: Canada
Affected count
69400 infusion sets
Manufactured in
14998 W 6th Ave Ste 830, Golden, CO, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1442-2020

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