Device product
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Z-0835-2021
Product summary
- Event
- Event 86939
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1426 cases
- Official record key
device-enforcement:Z-0835-2021
Official wording
Reason: 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 communicated. Calcium concentration is below manufacturing specification.
Code information: Lot Numbers: 20NXAC013 20NXAC035 Additional Affected lots as of 3/17/21: 20LXAC056 20LXAC041 20LXAC055 20LXAC057 20NXAC013 20NXAC035
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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 communicated. Calcium concentration is below manufacturing specification.