Recalls / —
—#132856
Product
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.
- FDA product code
- KOC — Accessories, Blood Circuit, Hemodialysis
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K022536
- Affected 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
Why it was recalled
Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope
Root cause (FDA determination)
Device Design
Action the firm took
FMCRTG, LLC representatives contacted Clinics on 12/19/14 by visit/telephone phone) and removed all CLiC units.
Recalling firm
- Firm
- Fresenius Medical Care Holdings, Inc.
- Address
- 920 Winter St, Waltham, Massachusetts 02451-1521
Distribution
- Distribution pattern
- CT, NY
Timeline
- Recall initiated
- 2014-12-19
- Posted by FDA
- 2015-02-03
- Terminated
- 2021-02-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #132856. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.