Modification of Sarns Two Stage Venous Cannula

• 3 recalls, same reason

  • Terminated Z-2102-2014 FDA Class II ·initiated 23 May 2014
  • Terminated Z-2096-2014 FDA Class II ·initiated 23 May 2014
  • Terminated Z-2100-2014 FDA Class II ·initiated 23 May 2014

  During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

• 7 recalls, same reason

  • Terminated Z-1224-2014 FDA Class II ·initiated 3 Mar 2014
  • Terminated Z-1220-2014 FDA Class II ·initiated 3 Mar 2014
  • Terminated Z-1221-2014 FDA Class II ·initiated 3 Mar 2014
  • Terminated Z-1218-2014 FDA Class II ·initiated 3 Mar 2014
  • Terminated Z-1219-2014 FDA Class II ·initiated 3 Mar 2014
  • Terminated Z-1223-2014 FDA Class II ·initiated 3 Mar 2014
  • Terminated Z-1222-2014 FDA Class II ·initiated 3 Mar 2014

  During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.

510(k) Number

K920902 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

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

• Clear Cardioplejia Delivery System

  Class II

  FDA 510(k) K823451 Active Cleared 14 Jan 1983

See all devices from 3M Health Care, Sarns →