Fresenius Crit Line in a Clip (CLiC) with SW version 2.51… recallZ-1047-2015 · Fresenius Medical Care Holdings, Inc. · initiated Dec 19, 2014
Class II Terminated All recalls posted in February 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope
FDA root cause category: Device Design
What the company is doing
FMCRTG, LLC representatives contacted Clinics on 12/19/14 by visit/telephone phone) and removed all CLiC units.
Recall details
- Recall number
- Z-1047-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 19, 2014
- Posted by the FDA
- Feb 3, 2015
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 35 units
- Product code
- KOC
- FDA submissions
- K022536
- Distribution
- CT, NY
Product description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
1 device cleared under K022536 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CombiSet Twister 03-2794-0Fresenius Medical Care Holdings, Inc. · ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS1 death91 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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