FDA-Device2021-01-20Class II
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings, Inc.
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
3083 cases
Manufactured in
920 Winter St Bld 950, N/A, Waltham, MA, United States
Products
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0833-2021Don't want to check this manually?
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