2008 K2 Hemodialysis Machine with software version 5.40, Models
Medical device recall Z-1278-2018. Published in FDA’s Enforcement Report on Apr 11, 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 Apr 11, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 16 states named in where it went
- 127 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?
When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.
127, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 0K0S151801 UDI 00840861100866 190630,(+Serial Number) UDI 00840861100859 PLS 190610, (+Serial Number 1K0S169898 1K0S169954 1K0S170154 1K0S170234 1K0S171275 1K0S171286 1K0S171421 1K0S171436 2K0S176243 2K0S176244 2K0S176257…
Every code shown here, 1,998 characters
Serial Numbers: 0K0S151801 UDI 00840861100866 190630,(+Serial Number) UDI 00840861100859 PLS 190610, (+Serial Number 1K0S169898 1K0S169954 1K0S170154 1K0S170234 1K0S171275 1K0S171286 1K0S171421 1K0S171436 2K0S176243 2K0S176244 2K0S176257 2K0S176264 2K0S176271 2K0S176273 2K0S176278 2K0S176280 2K0S176281 2K0S176283 2K0S176286 2K0S176443 2K0S176472 2K0S176633 4K0S188834 4K0S188841 4K0S188843 4K0S188987 4K0S189246 4K0S189293 4K0S189300 4K0S189353 4K0S189488 4K0S189797 4K0S189915 4K0S189939 4K0S190064 4K0S190067 4K0S190091 4K0S190111 4K0S190115 4K0S190119 4K0S190121 4K0S190126 4K0S190140 4K0S190141 4K0S190145 4K0S190146 4K0S190166 4K0S190173 4K0S190175 4K0S190183 4K0S190203 4K0S190212 4K0S190222 4K0S190226 4K0S191575 4K0S191910 5K0S193681 5K0S193682 5K0S193688 5K0S193689 5K0S193690 5K0S193696 5K0S193699 5K0S193701 5K0S193702 5K0S193707 5K0S193710 5K0S193711 5K0S193712 5K0S193713 5K0S193721 5K0S193732 5K0S193733 5K0S193734 5K0S193735 5K0S193736 5K0S193737 5K0S193740 5K0S193741 5K0S193747 5K0S193750 5K0S193753 5K0S193756 5K0S193757 5K0S193758 5K0S193761 5K0S193765 5K0S193769 5K0S193774 5K0S193776 5K0S193777 5K0S193778 5K0S193781 5K0S193783 5K0S193788 5K0S193789 5K0S193790 5K0S193794 5K0S193798 5K0S193799 5K0S193801 5K0S193808 5K0S193812 5K0S193820 5K0S193822 5K0S193823 5K0S193824 5K0S193830 5K0S193834 5K0S193835 5K0S193839 5K0S193842 5K0S193843 5K0S193851 5K0S193853 5K0S193854 5K0S193861 5K0S193864 5K0S193865 5K0S193866 5K0S193867 5K0S193872 5K0S193875 5K0S193877 5K0S193879 5K0S193883 5K0S193887 5K0S193889 5K0S193891 5K0S193892 5K0S193895 5K0S193898 5K0S193900 5K0S193901 5K0S193902 5K0S193903 5K0S193904 5K0S193905 5K0S193909 5K0S193910 5K0S193912 5K0S193914 5K0S193916 5K0S193917 5K0S193918 5K0S193919 5K0S193920 5K0S193921 5K0S193922 5K0S193924 5K0S193925 5K0S193927 5K0S193928 5K0S193929 5K0S193930 5K0S193932 5K0S193935 5K0S193937 5K0S193940 5K0S193944 5K0S193946 5K0S193948 5K0S193957 5K0S193963 5K0S193965 5K0S193966 5K0S193975 5K0S193976 5K0S193981 5K0S193983 5K0S193986…
FDA’s list runs to 2,699 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.
US Distribution to the states of: AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX.
The states and territories these words name
16 states and territories.
Every one of them
- Arkansas
- California
- Colorado
- Florida
- Georgia
- Illinois
- Massachusetts
- Maryland
- Minnesota
- North Carolina
- New York
- Ohio
- Pennsylvania
- South Carolina
- Tennessee
- Texas
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Dec 14, 2017.
- FDA classified it on Mar 30, 2018.
- FDA’s Enforcement Report published it on Apr 11, 2018.
- FDA terminated it on Sep 22, 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: E-Mail.
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 2,699 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
-
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.