Crit Line in a Clip (CLiC)
Medical device recall Z-2044-2016. Published in FDA’s Enforcement Report on Jun 29, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 29, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 875 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
875 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
S/N: 1C01M140014 1C01M140015 1C01M140020 1C01M140046 1C01M140050 1C01M140055 1C01M140063 1C01M140071 1C01M140075 1C01M140090 1C31M140024 1C31M140025 1C31M140026 1C31M140027 1C31M140028 1C31M140036 1C31M140037 1C31M140058 1C32M140015…
Every code shown here, 1,997 characters
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 1C42M140125 1C42M140127 1C42M140155 1C42M140163 1C42M140198 1C42M140227 1C42M140270 1C43M140006 1C43M140007 1C43M140028 1C43M140042 1C43M140043 1C43M140049 1C43M140050 1C43M140055 1C43M140058 1C43M140099 1C43M140104 1C43M140109 1C43M140122 1C43M140123 1C43M140124 1C43M140126 1C43M140127 1C43M140169 1C43M140170 1C43M140172 1C43M140173 1C43M140175 1C43M140176 1C43M140189 1C43M140197 1C43M140199 1C43M140201 1C43M140202 1C43M140203 1C43M140209 1C43M140230 1C43M140231 1C43M140233 1C43M140234 1C43M140248 1C43M140251 1C43M140252 1C43M140253 1C43M140254 1C43M140258 1C43M140261 1C43M140263 1C43M140265 1C43M140266 1C43M140270 1C43M140278 1C43M140279 1C43M140282 1C43M140286 1C43M140287 1C43M140290 1C43M140294 1C43M140295 1C43M140298 1C43M140300 1C43M140301 1C43M140302 1C43M140306 1C43M140310 1C43M140313 1C43M140314 1C43M140332 1C43M140333 1C43M140360 1C43M140390 1C43M140392 1C43M140409 1C43M140422 1C43M140424 1C44M140001 1C44M140002 1C44M140005 1C44M140011 1C44M140018 1C44M140020 1C44M140027 1C44M140035 1C44M140036 1C44M140047 1C44M140057 1C44M140065 1C44M140066 1C44M140068…
FDA’s list runs to 10,504 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Distributed US (nationwide)
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 24, 2016.
- FDA classified it on Jun 21, 2016.
- FDA’s Enforcement Report published it on Jun 29, 2016.
- FDA terminated it on Apr 30, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Fresenius Medical Care Renal Therapies Group, LLC, of Waltham, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 10,504 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.