Reported Sep 26, 2018 · Terminated
2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part…
Fresenius Medical Care Renal Therapies Group, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Renal Therapies Group, LLC · 920 Winter St · Waltham, MA · 02451-1521
Is this the product you have?
- 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit
- Part Number 191138 Product UsageIndicated for acute and chronic dialysis therapy
- Lot codes and dates
- 6T0S160600, 6T0S160624, 6T0S160672, 6T0S160695, 6T0S160732, 6T0S160740, 6T0S160773, 6T0S160781, 6T0S160785, 6T0S160841,
4T0S1359624T0S1359634T0S1359704T0S1359724T0S1359804T0S1359854T0S1359874T0S1360004T0S1360034T0S1360704T0S1360714T0S1360724T0S1360774T0S1360784T0S1360804T0S1360814T0S1360824T0S1360844T0S1360884T0S1360904T0S1360914T0S1361064T0S1361114T0S1361124T0S1361144T0S1361154T0S1361174T0S1361204T0S1361214T0S136123
- 6T0S160600, 6T0S160624, 6T0S160672, 6T0S160695, 6T0S160732, 6T0S160740, 6T0S160773, 6T0S160781, 6T0S160785, 6T0S160841,
- Amount recalled
- 40
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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