medical Class II Updated 2018-09-26

Fresenius Medical Care Renal Therapies Group, LLC recalls 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Appli

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
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