Company: Fresenius Medical Care Holdings, Inc.
Date of Enforcement Report 2/11/2015
Class lI:
PRODUCT
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.
Recall Number Z-1047-2015
REASON
Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope.
RECALLING FIRM/MANUFACTURER
Fresenius Medical Care Holdings, Inc.Waltham, MA on 12/19/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
CT, NY
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