Reported Sep 26, 2018 · Terminated
2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, 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 SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit
- Part Number 191138 Product UsageIndicated for acute and chronic dialysis therapy
- Lot codes and dates
- 3T0S119726, 3T0S119741, 3T0S119747, 3T0S119753, 3T0S119762, 3T0S119775, 3T0S119792, 3T0S119801, 3T0S119806, 3T0S119807, 3T0S119818, 3T0S119823, 3T0S119824, 3T0S119848, 3T0S119863, 3T0S119910, 3T0S119948, 3T0S119965, 3T0S119984, 3T0S120097, 3T0S120134, 3T0S120200,
1T0S1040901T0S1041081T0S1041161T0S1041661T0S1041691T0S1041881T0S1041891T0S1041911T0S1042161T0S1042241T0S1042401T0S1042491T0S1042781T0S1042931T0S1043031T0S1043101T0S1043241T0S1043251T0S1043341T0S1043573T0S1216804T0S1267174T0S1267644T0S1267820T0S1010390T0S1011230T0S1011440T0S1011820T0S1011970T0S1012200T0S1012310T0S1012320T0S1012360T0S1012380T0S1012400T0S1012520T0S1012980T0S1013240T0S1013290T0S1013410T0S1013440T0S1013450T0S1013523T0S1186413T0S1186613T0S1186623T0S1186703T0S1186753T0S1186823T0S1186953T0S1186983T0S1186993T0S1187023T0S1187033T0S1187213T0S1187233T0S1187263T0S1187343T0S118754
- 3T0S119726, 3T0S119741, 3T0S119747, 3T0S119753, 3T0S119762, 3T0S119775, 3T0S119792, 3T0S119801, 3T0S119806, 3T0S119807, 3T0S119818, 3T0S119823, 3T0S119824, 3T0S119848, 3T0S119863, 3T0S119910, 3T0S119948, 3T0S119965, 3T0S119984, 3T0S120097, 3T0S120134, 3T0S120200,
- Amount recalled
- 80
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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