medical Class II Updated 2021-01-20

Fresenius Medical Care Holdings, Inc. recalls Naturalyte Liquid Acid concentrate bottles, Product Code 08-

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 20NXAC013 20NXAC035 Additional Affected lots as of 3/17/21: 20LXAC056 20LXAC041 20LXAC055 20LXAC057 20NXAC013 20NXAC035
View official government recall

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