FDA Device recall Z-1047-2015
Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001
- FDA Device
- Class II
- terminated
- Published 2015-02-11
On 2015-02-11 the FDA classified a Class II recall of Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001 by Fresenius Medical Care Holdings, citing potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1047-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-19 |
| Published | 2015-02-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | CT, NY |
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.
Reason
Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope
Identifiers
| code_info | Serial Numbers: 1C31M140038 1C31M140040 1C31M140041 1C31M140042 1C31M140033 1C31M140034 1C31M140035 1C31M140030 1C…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1047-2015%22
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