Recall Z-0887-2016— Fresenius Medical Care Renal Therapies Group, LLC

Name: FDA recall Z-0887-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-18

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2016-01-18, terminated 2017-08-14. It names one FDA 510(k) clearance: K070177. Product: Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis. Reason: On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L..

Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-01-18
Terminated: 2017-08-14
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

Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis

Reason for recall

On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.

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