Recall Z-2686-2014— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-2686-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-23

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2014-06-23, terminated 2021-01-29. It names one FDA 510(k) clearance: K071387. Product: Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.. Reason: Product was held at temperature above the labeled recommended storage temperature.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-06-23
Terminated: 2021-01-29
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K071387 — FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LBFresenius Medical Care North America·cleared 2007-06-15

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 Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

Reason for recall

Product was held at temperature above the labeled recommended storage temperature

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