CLASS II Device recall · Reported 26 Sep 2018 · FDA Enforcement Report

2008t Hemodialysis System W/bibag recalled

Fresenius Medical Care Renal Therapies Group is recalling 2008t Hemodialysis System W/bibag, distributed nationwide in the US. The recall was initiated on 13 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes6T0S160600, 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

Quantity recalled40

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3195-2018
FDA event ID: 80875
Recalling firm: Fresenius Medical Care Renal Therapies Group, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 13 Jul 2018
FDA classified: 18 Sep 2018
Reported: 26 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

13 Jul 2018	Recall initiated by company
18 Sep 2018	Classified by FDA	+67 days
26 Sep 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide in the states of : CA, CT, MI, NC, and NY.

Nationwide California Connecticut Michigan North Carolina New York

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US Nationwide in the states of : CA, CT, MI, NC, and NY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 80875

Reported	Class	Recall	Company	Reason	Where
26 Sep 2018	CLASS II	2008t Hemodialysis Sys, With Cdx recalled	Fresenius Medical Care Renal Therapies Group	Device Malfunction	Nationwide

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