Jostra Arterial Perfusion Cannulae

• 3 recalls, same reason

  • Terminated Z-2159-2018 FDA Class II ·initiated 14 May 2018
  • Terminated Z-2160-2018 FDA Class II ·initiated 14 May 2018
  • Terminated Z-2161-2018 FDA Class II ·initiated 14 May 2018

  This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.

510(k) Number

K012774 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Jostra Arterial Perfusion Cannulae, Model a...

  Class II

  FDA 510(k) K012617 Active Cleared 6 Nov 2001

• Heater Cooler Unit, Model Hcu 30

  Class II

  FDA 510(k) K031544 Active Cleared 7 Aug 2003

• Jostra Vent Catheters, Models Lv & Hkv

  Class II

  FDA 510(k) K022022 Active Cleared 11 Sep 2002

• Els Cannula (Kit), Model M1210-88, M1510-88

  Class II

  FDA 510(k) K002857 Active Cleared 5 Oct 2000

• Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030

  Class II

  FDA 510(k) K030264 Active Cleared 26 Feb 2003

• Jostra Mecc System

  Class II

  FDA 510(k) K023132 Active Cleared 17 Dec 2002

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