Medical device recalls Moderate risk

Fresenius Medical Care Holdings, Inc. recalls Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for…

Recall date
December 19, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1047-2015
FDA classification
Class II
Brand / firm
Fresenius Medical Care Holdings, Inc.
Sold / distributed
CT, NY

Why it was recalled

Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope

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

What was recalled

Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment.

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