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.
This recall has been terminated (originally issued February 3, 2015).
- Recall Initiated
- December 19, 2014
- Posted
- February 3, 2015
- Terminated
- February 18, 2021
- Recall Number
- Z-1047-2015
- Quantity
- 35 units
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope
Distribution
CT, NY
Lot / Code Info
Serial Numbers: 1C31M140038 1C31M140040 1C31M140041 1C31M140042 1C31M140033 1C31M140034 1C31M140035 1C31M140030 1C31M140075 1C31M140031 1C31M140027 1C31M140054 1C31M140057 1C31M140060 1C31M140039 1C31M140056 1C32M140005, 1C32M140059, 1C32M140058, 1C32M140014, 1C32M140013, 1C32M140004, 1C32M140012, 1C32M140011, 1C32M140009, 1C32M140008, 1C32M140003, 1C32M140007, 1C32M140006, 1C32M140023, 1C32M140021, 1C32M140022, 1C32M140020, 1C31M140073, 1C31M140050
Root Cause
Device Design
Action Taken
FMCRTG, LLC representatives contacted Clinics on 12/19/14 by visit/telephone phone) and removed all CLiC units.