FDAFDA · Food and drugs·Recall number Z-0836-2021
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Published January 20, 2021 · Recall initiated: November 23, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- US Nationwide distribution.
- Lot
- Lot Numbers: 20NXAC033 Additional Affected lots as of 3/17/21: 20LXAC097 20NXAC033
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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