Recall Z-1827-2015— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-1827-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-20

Class II · Ongoing

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2015-05-20. It names one FDA 510(k) clearance: K071387. Product: NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.. Reason: Bacterial contamination..

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2015-05-20
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

NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

Reason for recall

Bacterial contamination.

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