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 Numbers1C32M140005, 1C32M140059, 1C32M140058, 1C32M140014, 1C32M140013, 1C32M140004, 1C32M140012, 1C32M140011, 1C32M140009, 1C32M140008, 1C32M140003, 1C32M140007, 1C32M140006, 1C32M140023, 1C32M140021, 1C32M140022, 1C32M140020, 1C31M140073, 1C31M140050
1C31M1400381C31M1400401C31M1400411C31M1400421C31M1400331C31M1400341C31M1400351C31M1400301C31M1400751C31M1400311C31M1400271C31M1400541C31M1400571C31M1400601C31M1400391C31M140056
- Serial Numbers
- 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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