Reported Jun 29, 2016 · Terminated

Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit…

Fresenius Medical Care Renal Therapies Group, LLC

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 Renal Therapies Group, LLC · 920 Winter St · Waltham, MA · 02451-1521

Is this the product you have?

  • Crit Line in a Clip (CLiC)
  • CliC P/NCL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T
  • Hemodialysis Machines as followsModel: 190895 2008T GEN 2 BIBAG w/o CDX 190713 2008T Hemodialysis SYS with CDX 190858 2008T Hemodialysis System w/o CDX 190766 2008T Hemodialysis System w/o CDX
Lot codes and dates
  • S/N

    875 of 875 codes

    • 1C01M140014
    • 1C01M140015
    • 1C01M140020
    • 1C01M140046
    • 1C01M140050
    • 1C01M140055
    • 1C01M140063
    • 1C01M140071
    • 1C01M140075
    • 1C01M140090
    • 1C31M140024
    • 1C31M140025
    • 1C31M140026
    • 1C31M140027
    • 1C31M140028
    • 1C31M140036
    • 1C31M140037
    • 1C31M140058
    • 1C32M140015
    • 1C32M140018
    • 1C32M140019
    • 1C32M140049
    • 1C32M140050
    • 1C32M140051
    • 1C32M140061
    • 1C40M140081
    • 1C40M140086
    • 1C40M140087
    • 1C40M140088
    • 1C41M140001
    • 1C41M140002
    • 1C41M140005
    • 1C41M140085
    • 1C41M140086
    • 1C41M140110
    • 1C41M140117
    • 1C41M140118
    • 1C41M140123
    • 1C41M140124
    • 1C41M140146
    • 1C41M140163
    • 1C41M140180
    • 1C41M140186
    • 1C41M140196
    • 1C41M140215
    • 1C41M140217
    • 1C41M140223
    • 1C41M140236
    • 1C41M140247
    • 1C41M140252
    • 1C41M140257
    • 1C41M140277
    • 1C41M140282
    • 1C41M140285
    • 1C41M140288
    • 1C41M140291
    • 1C41M140306
    • 1C41M140307
    • 1C41M140308
    • 1C41M140312
Amount recalled
875 units

Where it was sold

  • Nationwide

Why it was recalled

Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 30, 2021 · Data as of Sep 19, 5:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.