Z-3194-2018Class II

2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade...

Name: Z-3194-2018 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade...
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2018-07-13
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2018-07-13 / Terminated

FDA source

Fresenius Medical Care Renal Therapies Group, LLC began a recall of 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for... on 2018-07-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3194-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-13
Posted: 2018-09-19
Terminated: 2019-09-17
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: 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.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: 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 root cause: Under Investigation by firm
Action: On 07/13/2018 phone calls were immediately conducted to the affected clinics. Contact was made to the Technical Service Directors explaining issue and to disable the Auto Start Function on their BlueStar SW v2.71 installed 2008T Hemodialysis Machines.
Quantity in commerce: 80
Distribution: US Nationwide in the states of : CA, CT, MI, NC, and NY.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3194-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3194-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-18
Z-3195-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-18

Product code KDI

K173972Class II2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC / cleared 2018-05-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)