FDA Device recall Z-2044-2016
Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and…
- FDA Device
- Class II
- terminated
- Published 2016-06-29
On 2016-06-29 the FDA classified a Class II recall of Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and… by Fresenius Medical Care Renal Therapies Group, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2044-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-24 |
| Published | 2016-06-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fresenius Medical Care Renal Therapies Group |
| Distribution | US |
Product
Crit Line in a Clip (CLiC). CliC P/N: CL 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 follows: Model: 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
Reason
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.
Identifiers
| code_info | S/N: 1C01M140014 1C01M140015 1C01M140020 1C01M140046 1C01M140050 1C01M140055 1C01M140063 1C01M140071 1C01M1400…S/N: 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 1C41M140318 1C42M140011 1C42M140012 1C42M140026 1C42M140040 1C42M140044 1C42M140051 1C42M140058 1C42M140061 1C42M140070 1C42M140078 1C42M140081 1C42M140086 1C42M140091 1C42M140120 1C42M140124 1C42M1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2044-2016%22
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