2008T HEMODIALYSIS SYS, WITH CDX
Medical device recall Z-3194-2018. Published in FDA’s Enforcement Report on Sep 26, 2018.
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 Sep 26, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 5 states named
- 80 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?
In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be greyed out when the machine is powered up and a mandatory rinse should be required. However, if a power failure or interruption occurs during the cleaning/disinfection program with the auto-start feature enabled, the machine enters the dialysis program even though the dialysis program button is disabled and the mandatory rinse has not been performed. As a result, disinfecting chemical may not be completely removed from the machine before starting a treatment and disinfectant could exist in the dialysate delivered to the patient.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
80, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
3T0S119726, 3T0S119741, 3T0S119747, 3T0S119753, 3T0S119762, 3T0S119775, 3T0S119792, 3T0S119801, 3T0S119806, 3T0S119807, 3T0S119818, 3T0S119823, 3T0S119824, 3T0S119848, 3T0S119863, 3T0S119910, 3T0S119948, 3T0S119965, 3T0S119984, 3T0S120097,…
Every code shown here, 912 characters
3T0S119726, 3T0S119741, 3T0S119747, 3T0S119753, 3T0S119762, 3T0S119775, 3T0S119792, 3T0S119801, 3T0S119806, 3T0S119807, 3T0S119818, 3T0S119823, 3T0S119824, 3T0S119848, 3T0S119863, 3T0S119910, 3T0S119948, 3T0S119965, 3T0S119984, 3T0S120097, 3T0S120134, 3T0S120200, 1T0S104090 1T0S104108 1T0S104116 1T0S104166 1T0S104169 1T0S104188 1T0S104189 1T0S104191 1T0S104216 1T0S104224 1T0S104240 1T0S104249 1T0S104278 1T0S104293 1T0S104303 1T0S104310 1T0S104324 1T0S104325 1T0S104334 1T0S104357 3T0S121680 4T0S126717 4T0S126764 4T0S126782 0T0S101039 0T0S101123 0T0S101144 0T0S101182 0T0S101197 0T0S101220 0T0S101231 0T0S101232 0T0S101236 0T0S101238 0T0S101240 0T0S101252 0T0S101298 0T0S101324 0T0S101329 0T0S101341 0T0S101344 0T0S101345 0T0S101352 3T0S118641 3T0S118661 3T0S118662 3T0S118670 3T0S118675 3T0S118682 3T0S118695 3T0S118698 3T0S118699 3T0S118702 3T0S118703 3T0S118721 3T0S118723 3T0S118726 3T0S118734 3T0S118754
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.
US Nationwide in the states of : CA, CT, MI, NC, and NY.
The states and territories these words name
- California
- Connecticut
- Michigan
- North Carolina
- New York
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 Jul 13, 2018.
- FDA classified it on Sep 18, 2018.
- FDA’s Enforcement Report published it on Sep 26, 2018.
- FDA terminated it on Sep 17, 2019.
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: Telephone.
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.”
- 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
-
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.