Recall Z-1010-2018— Fresenius Medical Care Renal Therapies Group, LLC

Name: FDA recall Z-1010-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-29

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2017-09-29, terminated 2018-08-09. It names one FDA 510(k) clearance: K070177. Product: 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.. Reason: 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..

Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-09-29
Terminated: 2018-08-09
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K070177 — FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIESFresenius Medical Care North America·cleared 2007-03-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.