FDA Device recall Z-3195-2018
2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product…
- FDA Device
- Class II
- terminated
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class II recall of 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product… by Fresenius Medical Care Renal Therapies Group, citing 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 mach….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3195-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-13 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fresenius Medical Care Renal Therapies Group |
| Distribution | US |
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.
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.
Identifiers
| code_info | 6T0S160600, 6T0S160624, 6T0S160672, 6T0S160695, 6T0S160732, 6T0S160740, 6T0S160773, 6T0S160781, 6T0S160785, 6T0S160841,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 1…
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
All Fresenius Medical Care Renal Therapies Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3195-2018%22
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