Medical device recalls Moderate risk

CME America, LLC recalls BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage:…

Recall date
January 14, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1886-2020
FDA classification
Class II
Brand / firm
CME America, LLC
Sold / distributed
US Nationwide distribution including in the states of AK, CA, IL, KS, MA, MO, and SD. No O.U.S.

Why it was recalled

The filter installed onto the tube set may have the incorrect pore size.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.

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