2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX
Medical device recall Z-1549-2015. Published in FDA’s Enforcement Report on May 6, 2015.
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 May 6, 2015. 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
- 133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213) 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?
The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers: 0K0S151413 1K0S167702-7721 1K0S169224-244 1K0S170300-311 1K0S171475-499 1K0S171807-849 1K0S172042-061 1K0S172179-199 1K0S172200-205 1K0S172263-266 2K0S174112-149 2K0S174228-246 2K0S175602-628 2K0S179477-501 2K0S180512…
Every code shown here, 1,997 characters
Serial numbers: 0K0S151413 1K0S167702-7721 1K0S169224-244 1K0S170300-311 1K0S171475-499 1K0S171807-849 1K0S172042-061 1K0S172179-199 1K0S172200-205 1K0S172263-266 2K0S174112-149 2K0S174228-246 2K0S175602-628 2K0S179477-501 2K0S180512 2K0S180513 2K0S180516-533 2K0S180542 2K0S180543 2K0S180546 2K0S180628 2K0S180629 2K0S181311-332 2K0S181338-340 2K0S181343-347 2K0S181705-719 3K0S182625-659 3K0S183305-324 3K0S183906-920 3K0S183971-980 3K0S184849-912 3K0S185281-284 3K0S185307-311 3K0S185716-745 3K0S185974-989 3K0S185991-998 3K0S186031-045 3K0S186933-962 3K0S186989-7002 4K0S190280 4K0S190306- 4K0S190307 4K0S190309 4K0S190313 4K0S190319 4K0S190509-543 4K0S190829-854 4K0S191122-141 4K0S191229-234 4K0S191511-513 4K0S191569-572 4K0S191578- 588 4K0S192226-245 4K0S192512 4K0S192514-517 4K0S192520 4K0S192522-524 4K0S192526 4K0S192528 4K0S192529 4K0S192533 4K0S192536 4K0S192538 4K0S192540 4K0S192729 4K0S192735 4K0S-J232 4K0S-J943-J944 4K0S-J947-J952 4K0S-L720-L723 4K0S-M703-M708 4K0S-N151- N160 4K0S-N842- N850 4K0S-N913 4K0S-P288- P299 4K0S-P980- P982 4K0S-Q634- Q643 4K0S-Q688- Q697 4K0S-R079- R083 4K0S-R106- R115 4K0S-R134-R138 4K0S-S703- S722 5K0S-159D- 168D 5K0S-180C- 185C 5K0S-305C- 312C 5K0S-320C- 321C 5K0S-322B 5K0S-354D- 363D 5K0S-451B 5K0S-453B-457B 5K0S-459B- 470B 5K0S-866B- 869B 5K0S-877D- 886D 5K0S-T139 5K0S-T880- T899 5K0S-U131 5K0S-V190- V204 5K0S-X981- X983 5K0S-X986- X990 5K0S-Y001- Y010 5K0S-Z650- Z669 6K0S-004Q 6K0S-006M 6K0S-006Q- 014Q 6K0S-007M- 11M 6K0S-008R- 015R 6K0S-016M- 027M 6K0S-017R- 019R 6K0S-027Q- 031Q 6K0S-050M- 053M 6K0S-056N- 063N 6K0S-085L 6K0S-092L 6K0S-191E- 195E 6K0S-216E- 220E 6K0S-317L- 327L 6K0S-318H- 327H 6K0S-331H- 340H 6K0S-431N- 432N 6K0S-435N- 438N 6K0S-466G- 474G 6K0S-467K- 373K 6K0S-469J- 475K 6K0S-476G- 485G 6K0S-477J- 493J 6K0S-477K- 492K 6K0S-501F- 517F 6K0S-532F- 534F 6K0S-610L 6K0S-668L- 673L 6K0S-715R- 718R 6K0S-721R 6K0S-722R 6K0S-725R- 732R 6K0S-745N- 758N 6K0S-770R- 783R 6K0S-787R 6K0S-801K- 803K 6K0S-805K- 822K 6K0S-834N…
FDA’s list runs to 3,548 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.
Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.
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.
The words say it went outside the United States too.
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 Feb 20, 2015.
- FDA classified it on Apr 29, 2015.
- FDA’s Enforcement Report published it on May 6, 2015.
- FDA terminated it on May 18, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Fresenius Medical Care Holdings, Inc., 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 3,548 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.