FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Renal Therapies Group, LLC: 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.
- Recall number
- Z-3195-2018
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Product
- 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.
- Status
- Terminated
- Initiated
- 2018-07-13
- Posted
- not on file
- Terminated
- 2019-09-17
- Reason
- 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.
- 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
- 40
- Distribution
- US Nationwide in the states of : CA, CT, MI, NC, and NY.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K173972"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3001451489
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28