Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0839-2021)

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 drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Product Classification:

Class II

Date Initiated: November 23, 2020

Date Posted: January 20, 2021

Recall Number: Z-0839-2021

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: 224 drums

Code Information:

Lot Numbers: 20LXAC025 20LXAC081 20LXAC082 20LXAC083 Additional Affected lots as of 3/17/21: 20LXAC029 20NXAC021 20LXAC026 20LXAC065 20LXAC028 20NXAC029 20LXAC071 20LXAC103 20LXAC027 20LXAC070 20LXAC067 20NXAC019 20LXAC082 20LXAC025 20LXAC081 20LXAC083

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated