Fresenius Medical Care Renal Therapies Group, LLC: Medical Device Recall in 2018 - (Recall #: Z-2110-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used.

Product Classification:

Class II

Date Initiated: May 2, 2018

Date Posted: June 13, 2018

Recall Number: Z-2110-2018

Event ID: 80101

Reason for Recall:

The bottles are mislabeled with an incorrect part number.

Status: Terminated

Product Quantity: 1060 cases (4240 bottles)

Code Information:

Lot Code: 18CXAC095

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states: CA, IA, IL, IN, KS, MD, MI, MN, MS, NE, NJ, NV, OK, PA, SD, TX, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated