Shiley Specialized Tracheostomy Tube

• 19 recalls, same reason

  • Terminated Z-1505-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1503-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1501-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1516-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1518-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1508-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1522-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1519-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1506-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1502-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1515-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1517-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1521-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1509-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1504-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1520-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1500-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1523-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1507-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010

  Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.

510(k) Number

K903435 ↗

FDA Product Code

JOH

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

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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