Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2087-2021)

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 Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.

Product Classification:

Class II

Date Initiated: April 28, 2021

Date Posted: July 28, 2021

Recall Number: Z-2087-2021

Event ID: 87998

Reason for Recall:

Exposed to freezing temperatures due to refrigerated truck malfunctions

Status: Terminated

Product Quantity: 120 Bags

Code Information:

Lot Number: 21ATBC004 UDI: (01)00840861101955

Distribution Pattern:

US Distribution to: TX only

Voluntary or Mandated:

Voluntary: Firm initiated