Fresenius Medical Care Holdings DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low recall — FDA D-0607-2021
Temperature Abuse: Product exposed to temperature outside specified limits.
Overview of recall records associated with Fresenius Medical Care Holdings, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 80, Class III: 6.
Temperature Abuse: Product exposed to temperature outside specified limits.
AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination…
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
This page summarizes recall records in which the official source identifies Fresenius Medical Care Holdings, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.