Use caution Medical device recall · FDA · Published July 13, 2018

Fresenius Medical Care 2008T Hemodialysis System Recall: Power Failure Risk During

Fresenius Medical Care recalls 2008T Hemodialysis Systems with BlueStar Premium Upgrade Kit due to risk of disinfectant not fully removed during power failures, potentially contaminating patient dialysate.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3195-2018Medical device Fresenius Medical Care ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmFresenius Medical Care Renal Therapies Group, LLC920 Winter St · Waltham, MA 02451-1521

✎ GovInfoNow plain-language explainer

Fresenius Medical Care is recalling certain 2008T hemodialysis systems that come with the BlueStar Premium Upgrade Kit. If a power failure occurs during cleaning, the machine may start dialysis without completing a mandatory rinse, risking disinfectant contamination in the patient's treatment. Read more at govinfonow.com/recall/70602-fresenius-medical-care-2008t-hemodialysis-system-recall-power-failure-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/70602-fresenius-medical-care-2008t-hemodialysis-system-recall-power-failure-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-3195-2018

Cite this page

“Fresenius Medical Care 2008T Hemodialysis System Recall: Power Failure Risk During.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70602-fresenius-medical-care-2008t-hemodialysis-system-recall-power-failure-risk. Based on FDA recall #Z-3195-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3195-2018%22&limit=1).

The FDA announced on July 13, 2018, that Fresenius Medical Care Renal Therapies Group, LLC voluntarily recalled the 2008T Hemodialysis System with BIBAG. The agency stated the recall addresses a hazard where disinfectant could remain in the machine and be delivered to patients during treatment.

How to tell if you have it

Brand: Fresenius Medical Care
Product: 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766
Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138
Units affected: 40
Sold nationwide in CA, CT, MI, NC, and NY

The hazard

According to the FDA, if a power failure or interruption occurs during the cleaning/disinfection program with the auto-start feature enabled, the machine may enter the dialysis program before the mandatory rinse is 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.

Context

GovInfoNow's records show Fresenius Medical Care Renal Therapies Group, LLC has 15 other recalls on record since 2017-09-29. Other recent recalls of similar products include Fresenius Medical Care 5008X HD/HDF with Twister Tubing Set (2026-08-10), Fresenius Medical Care CombiSet Hemodialysis Tubing Set Recall (2026-07-29), and Fresenius Medical Care GRANUFLO Dry Acid Concentrate Recall (2026-07-14). Additional similar product recalls include Fresenius Medical Care 5008X CAREsystem Recall (2025-10-25), Fresenius 5008X Blood Tubing Set Recall (2026-05-11), and Vantive US Healthcare OXIRIS Dialyzer Recall (2026-01-06).

How to tell if you have this one

Check for the part number 190766 on the 2008T Hemodialysis System. The recall applies only to units sold with the BlueStar Premium Upgrade Kit (part number 191138).

Brand
Fresenius Medical Care
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US Nationwide in the states of : CA, CT, MI, NC, and NY.

Recall number	Product, codes & lots	Quantity
Z-3194-2018	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.; 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	80
Z-3195-2018	2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.; 6T0S160600, 6T0S160624, 6T0S160672, 6T0S160695, 6T0S160732, 6T0S160740, 6T0S160773, 6T0S160781, 6T0S160785, 6T0S160841, 4T0S135962 4T0S135963 4T0S135970 4T0S135972 4T0S135980 4T0S135985 4T0S135987 4T0S136000 4T0S136003 4T0S136070 4T0S136071 4T0S136072 4T0S136077 4T0S136078 4T0S136080 4T0S136081 4T0S136082 4T0S136084 4T0S136088 4T0S136090 4T0S136091 4T0S136106 4T0S136111 4T0S136112 4T0S136114 4T0S136115 4T0S136117 4T0S136120 4T0S136121 4T0S136123	40

Based on the official FDA remedy

What to do — step by step

Check for Power Failure Risk
If your machine has the BlueStar Premium Upgrade Kit (part number 191138), it may start dialysis during a power failure without completing a mandatory rinse.
Contact Manufacturer
Reach out to Fresenius Medical Care for guidance on safe use or potential remedies.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 5 states.

FDA distribution: “US Nationwide in the states of : CA, CT, MI, NC, and NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Connecticut, Michigan, New York, North Carolina.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

Jul 13, 2018Firm started the recall
Sep 18, 2018FDA classified it Class II
Sep 26, 2018Published in FDA’s Enforcement Report
Sep 17, 2019FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/70602-fresenius-medical-care-2008t-hemodialysis-system-recall-power-failure-risk">Fresenius Medical Care 2008T Hemodialysis System Recall: Power Failure Risk During (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-3195-2018 (July 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3195-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.