Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0816-2021)

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, Model Number 08-2301-3 - 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-0816-2021

Event ID: 86855

Reason for Recall:

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

Status: Ongoing

Product Quantity: 8272 cases

Code Information:

Lot Numbers: 20LXAC056 20LXAC057 20NXAC038 20LXAC041 20LXAC055 Additional affected lots as of 3/17/21: 20NXAC013 20NXAC035

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated