Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model 08-4000-Lb

• • Ongoing Z-2373-2015 FDA Class II ·initiated 16 Jul 2015

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

• • Ongoing Z-1827-2015 FDA Class II ·initiated 20 May 2015

  Bacterial contamination.

• • Ongoing Z-1639-2014 FDA Class I ·initiated 10 Apr 2014

  Naturalyte Liquid Bicarbonate maybe contaminated

• • Terminated Z-2686-2014 FDA Class II ·initiated 23 Jun 2014

  Product was held at temperature above the labeled recommended storage temperature

• • Terminated Z-1739-2014 FDA Class III ·initiated 1 May 2014

  Container cap may contain foreign material- 0.60% - 0.80% Manganese

• • Terminated Z-2551-2011 FDA Unclassified (pre-2012) ·initiated 23 Mar 2011

  Mislabeled: incorrect lot number printed on case labels

510(k) Number

K071387 ↗

FDA Product Code

KPO

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000 Series Open recall

  Class II

  FDA 510(k) K070177 Active Cleared 29 Mar 2007

• Crit-Line Clip (Clic) Blood Chamber

  Class II

  FDA 510(k) K152953 Active Cleared 5 Nov 2015

• Optiflux dialyzer Open recall

  Class II

  FDA 510(k) K162488 Active Cleared 6 Apr 2017

• Fresenius Art Hemoadsorption System

  Unclassified

  FDA 510(k) K050273 Active Cleared 8 Jun 2005

• Frsenius Pd Iqcard Cycler

  Class II

  FDA 510(k) K002892 Active Cleared 5 Apr 2001

• Fresenius on Line Clearance Monitor with the Addition of Access Flow Determination

  Class II

  FDA 510(k) K991520 Active Cleared 30 Jul 1999

See all devices from Fresenius Medical Care North America →