Shiley Vein Irrigation Cannula (Beveled & Blunt)

• 2 recalls, same reason

  • Terminated Z-2464-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2463-2020 FDA Class II ·initiated 24 Apr 2020

  The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.

510(k) Number

K900753 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Stockert-Shiley Caps Venous Occlusion Clamp

  Class I

  FDA 510(k) K864890 Active Cleared 19 Feb 1987

• Basic Heater-Cooler Unit, 115/100V 16-02-20

  Class II

  FDA 510(k) K883330 Active Cleared 26 Sep 1988

• Schneider-Shiley Y-Connector with Rotator

  Class II

  FDA 510(k) K862464 Active Cleared 28 Aug 1986

• Expanded Use for Shiley 3l Cardiotomy Reservoir

  Class II

  FDA 510(k) K872721 Active Cleared 23 Sep 1987

• Shiley Venous Reservoir

  Class II

  FDA 510(k) K854841 Active Cleared 10 Feb 1986

• Arterial Embolectomy Catheter

  Class II

  FDA 510(k) K840198 Active Cleared 3 Aug 1984

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