Fresenius Medical Care Renal Therapies Group, LLC: Medical Device Recall in 2018 - (Recall #: Z-1010-2018)

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 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle 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.

Product Classification:

Class II

Date Initiated: September 29, 2017

Date Posted: March 21, 2018

Recall Number: Z-1010-2018

Event ID: 79236

Reason for Recall:

The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.

Status: Terminated

Product Quantity: 598 cases

Code Information:

Lot # 17KTAC076; UDI-00840861101696

Distribution Pattern:

US Distribution to states of: CA, FL, KS, LA, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated