Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0838-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Product Classification:

Class II

Date Initiated: November 23, 2020

Date Posted: January 20, 2021

Recall Number: Z-0838-2021

Event ID: 86939

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.

Status: Ongoing

Product Quantity: 912 cases

Code Information:

Lot Numbers: 20LXAC088 Additional Affected lots as of 3/17/21: 20LXAC088 20LXAC052

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated