Cobe Heart/Lung Perfusion and Cardioplegia Pack

• • Terminated Z-0770-2019 FDA Class II ·initiated 9 Nov 2018

  4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded.

• • Terminated Z-1018-2016 FDA Class III ·initiated 19 Jan 2016

  The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not display.

• • Terminated Z-1985-2013 FDA Class II ·initiated 8 Jul 2013

  Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.

• 22 recalls, same reason

  • Terminated Z-0381-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0382-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0370-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0387-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0374-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0390-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0375-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0391-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0378-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0376-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0389-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0379-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0385-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0386-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0380-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0384-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0371-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0372-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0373-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0377-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0383-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010
  • Terminated Z-0388-2011 FDA Unclassified (pre-2012) ·initiated 7 Oct 2010

  Defective product packaging may compromise product sterility.

• 16 recalls, same reason

  • Terminated Z-1093-2010 FDA Unclassified (pre-2012) ·initiated 30 Dec 2009
  • Terminated Z-1090-2010 FDA Unclassified (pre-2012) ·initiated 30 Dec 2009
  • Terminated Z-1097-2010 FDA Unclassified (pre-2012) ·initiated 30 Dec 2009
  • Terminated Z-1084-2010 FDA Unclassified (pre-2012) ·initiated 30 Dec 2009
  • Terminated Z-1086-2010 FDA Unclassified (pre-2012) ·initiated 30 Dec 2009
  • Terminated Z-1087-2010 FDA Unclassified (pre-2012) ·initiated 30 Dec 2009
  • Terminated Z-1098-2010 FDA Unclassified (pre-2012) ·initiated 30 Dec 2009
  • Terminated Z-1089-2010 FDA Unclassified (pre-2012) ·initiated 30 Dec 2009
  • Terminated Z-1099-2010 FDA Unclassified (pre-2012) ·initiated 30 Dec 2009
  • Terminated Z-1091-2010 FDA Unclassified (pre-2012) ·initiated 30 Dec 2009
  • Terminated Z-1092-2010 FDA Unclassified (pre-2012) ·initiated 30 Dec 2009
  • Terminated Z-1096-2010 FDA Unclassified (pre-2012) ·initiated 30 Dec 2009
  • Terminated Z-1088-2010 FDA Unclassified (pre-2012) ·initiated 30 Dec 2009
  • Terminated Z-1094-2010 FDA Unclassified (pre-2012) ·initiated 30 Dec 2009
  • Terminated Z-1085-2010 FDA Unclassified (pre-2012) ·initiated 30 Dec 2009
  • Terminated Z-1095-2010 FDA Unclassified (pre-2012) ·initiated 30 Dec 2009

  Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

510(k) Number

K881330 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Flowmeter, Optiflo Gas

  Class II

  FDA 510(k) K790546 Active Cleared 11 May 1979

• Cobe Ppd 1.9

  Class II

  FDA 510(k) K812336 Active Cleared 31 Aug 1981

• Cobe Spectra Blood Component Separator Therapeutic

  Unclassified

  FDA 510(k) K900105 Active Cleared 22 Mar 1991

• Cobe Emergency Power Source 43610-000

  Class II

  FDA 510(k) K842138 Active Cleared 3 Aug 1984

• Centry 2 Ultrafiltration Control Kit, #018762-002

  Class II

  FDA 510(k) K881062 Active Cleared 21 Apr 1988

• Cobe Rx Meter

  Class II

  FDA 510(k) K830629 Active Cleared 6 Apr 1983

See all devices from Cobe Laboratories, Inc. →