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

___________________________________

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT


Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.