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
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
- S/N
- 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.
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