Cl II Fresenius Crit Line in a Clip

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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