Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0825-2021)

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, Model Number 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 7, 2020

Date Posted: January 20, 2021

Recall Number: Z-0825-2021

Event ID: 86855

Reason for Recall:

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Status: Ongoing

Product Quantity: 592 drums

Code Information:

Lot Numbers: 20LXAC070 20LXAC103 20NXAC021 20LXAC100 20LXAC026 20LXAC027 20LXAC028 20LXAC029 20LXAC065 20LXAC067 20LXAC071 20NXAC001 20NXAC019 20NXAC020 20NXAC029 Additional affected lots as of 3/17/21: 20LXAC103 20LXAC082 20LXAC025 20LXAC081 20LXAC083

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated