Clear Cardioplejia Delivery System

• • Terminated Z-0158-2015 FDA Class II ·initiated 1 Mar 2011

  Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line

• 13 recalls, same reason

  • Terminated Z-2153-2010 FDA Unclassified (pre-2012) ·initiated 8 Jun 2010
  • Terminated Z-2154-2010 FDA Unclassified (pre-2012) ·initiated 8 Jun 2010
  • Terminated Z-2149-2010 FDA Unclassified (pre-2012) ·initiated 8 Jun 2010
  • Terminated Z-2159-2010 FDA Unclassified (pre-2012) ·initiated 8 Jun 2010
  • Terminated Z-2155-2010 FDA Unclassified (pre-2012) ·initiated 8 Jun 2010
  • Terminated Z-2162-2010 FDA Unclassified (pre-2012) ·initiated 8 Jun 2010
  • Terminated Z-2151-2010 FDA Unclassified (pre-2012) ·initiated 8 Jun 2010
  • Terminated Z-2152-2010 FDA Unclassified (pre-2012) ·initiated 8 Jun 2010
  • Terminated Z-2158-2010 FDA Unclassified (pre-2012) ·initiated 8 Jun 2010
  • Terminated Z-2156-2010 FDA Unclassified (pre-2012) ·initiated 8 Jun 2010
  • Terminated Z-2161-2010 FDA Unclassified (pre-2012) ·initiated 8 Jun 2010
  • Terminated Z-2157-2010 FDA Unclassified (pre-2012) ·initiated 8 Jun 2010
  • Terminated Z-2160-2010 FDA Unclassified (pre-2012) ·initiated 8 Jun 2010

  Vent port may be occluded and prevent delivery of fluid

510(k) Number

K823451 ↗

FDA Product Code

DTR

Device Class

Class II

Regulation

21 CFR Part 870.4240

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Monitor Kits, Blood Level

  Class II

  FDA 510(k) K781145 Active Cleared 27 Jul 1978

• 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System

  Class II

  FDA 510(k) K950739 Active Cleared 17 Nov 1995

• Flexible Arterial Cannulae

  Class II

  FDA 510(k) K771499 Active Cleared 16 Aug 1977

• Battery Operated Flow Rate Computer

  Class II

  FDA 510(k) K760756 Active Cleared 15 Oct 1976

• Centrifugal Pump System Lx/Dx Version

  Class II

  FDA 510(k) K882758 Active Cleared 13 Oct 1988

• Sarns Filtered Cardiotomy Reservoir

  Class II

  FDA 510(k) K860702 Active Cleared 28 May 1986

See all devices from 3M Health Care, Sarns →