Drake Willock System 1000 Dialysate Delivery Syst

• • Terminated Z-1253-06 FDA Unclassified (pre-2012) ·initiated 21 Jun 2006 ·on shared 510(k) K910215

  The UF Removal Regulators were assembled incorrectly. The mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy.

• • Terminated Z-0766-06 FDA Unclassified (pre-2012) ·initiated 24 Feb 2006

  The older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators may become cracked due to mechanical and thermal stress. If either of these parts become cracked during patient treatment, there is the potential for an ultrafiltration error to occur, which can result in excessive removal of fluid from the patient.

• • Terminated Z-0347-06 FDA Unclassified (pre-2012) ·initiated 18 Nov 2005 ·on shared 510(k) K910215

  Potential for fluid or air to be passed through the venous line clamp if the tubing is not centered in the clamp and extends beyond the edge of the clamp's pinch zone. This could result in an air emboli condition.

• • Terminated Z-0395-05 FDA Unclassified (pre-2012) ·initiated 28 May 2003

  The air detector may not detect air bubbles consistently at the selected limit.

• • Terminated Z-0833-03 FDA Unclassified (pre-2012) ·initiated 20 Mar 2003

  The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.

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

510(k) Number

K910215 ↗

FDA Product Code

FKP

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Drake Willock Central Dialysate Delivery System

  Class II

  FDA 510(k) K862304 Active Cleared 9 Sep 1986

• 8810 Pump-Pump Single Needle Device

  Class II

  FDA 510(k) K873279 Active Cleared 23 Oct 1987

• Ultrx(Tm) 850 Artificial Kidney

  Class II

  FDA 510(k) K884353 Active Cleared 8 Dec 1988

• Cd Home Dialyservice Hemodialysis Tray

  Class II

  FDA 510(k) K925654 Active Cleared 30 Mar 1994

• Drake Willock Reverse Osmosis Water Treatment Syst

  Class II

  FDA 510(k) K894106 Active Cleared 8 Nov 1989

• Wurtz Choley Clip (Tm)

  Class I

  FDA 510(k) K901520 Active Cleared 26 Jun 1990

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