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…
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
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…
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
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…
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. 2) 3 Lots contain a kit component that expires prior to the expiration…
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…
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
Class IFDA: TerminatedBoston Scientific Corporation
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…
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
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…
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
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…
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
About the 2021 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.