Z-0835-2021 Class II Ongoing
FDA device recall Z-0835-2021 was initiated by Fresenius Medical Care Holdings, Inc. on November 23, 2020 and is designated Class II. Reason for recall: 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 … The recall status is ongoing. Affected quantity: 1426 cases.
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2021
- Initiation Date
- November 23, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1426 cases
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Lot Numbers: 20NXAC013 20NXAC035 Additional Affected lots as of 3/17/21: 20LXAC056 20LXAC041 20LXAC055 20LXAC057 20NXAC013 20NXAC035