Reported Feb 11, 2015 · Terminated

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

Fresenius Medical Care Holdings, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Fresenius Medical Care Holdings, Inc. · 920 Winter St · Waltham, MA · 02451-1521

Is this the product you have?

  • Fresenius Crit Line in a Clip (CLiC) with SW version 2.51
  • Model NumberCL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment
Lot codes and dates
  • 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
Amount recalled
35 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 18, 2021 · Data as of Sep 19, 6:14 PM UTC

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