Recall Z-2373-2015— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-2373-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-16

Class II · Ongoing

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2015-07-16. It names one FDA 510(k) clearance: K071387. Product: Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB. Reason: Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination..

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2015-07-16
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 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB

Reason for recall

Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.

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