Fresenius 2008K @home with Wireless Wetness Detector

• • Terminated Z-1549-2015 FDA Class II ·initiated 20 Feb 2015 ·on shared 510(k) K070049

  The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.

• • Terminated Z-0629-2014 FDA Class II ·initiated 12 Nov 2013 ·on shared 510(k) K070049

  2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup

• 3 recalls, same reason

  • Terminated Z-0184-2014 FDA Class II ·initiated 29 Aug 2013
  • Terminated Z-0185-2014 FDA Class II ·initiated 29 Aug 2013
  • Terminated Z-0186-2014 FDA Class II ·initiated 29 Aug 2013

  Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss

• • Terminated Z-3269-2011 FDA Unclassified (pre-2012) ·initiated 11 Aug 2011 ·on shared 510(k) K070049

  Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions

• • Terminated Z-3083-2011 FDA Unclassified (pre-2012) ·initiated 4 May 2011

  Upgrade software to implement new on screen graphics and instructions, the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in order to conform to approved 510(k)

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K070049 ↗

FDA Product Code

ONW

Device Class

Class II

Regulation

21 CFR Part 876.5860

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

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