Shikey Tracheostomy Tubes and Accessories

• • Terminated Z-2174-2012 FDA Class I ·initiated 18 Jul 2012

  Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the connections and functions of the inner and outer cannula which were observed during mechanical ventilation of patients.

• 22 recalls, same reason

  • Terminated Z-1470-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1465-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1491-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1463-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1479-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1476-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1469-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1466-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1488-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1473-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1490-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1477-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1481-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1464-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1462-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1472-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1467-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1471-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1480-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1489-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1468-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-1478-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010

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

510(k) Number

K962173 ↗

FDA Product Code

JOH

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Percutaneous Transluminal Angioplasty Catheter

  Class II

  FDA 510(k) K905773 Active Cleared 30 Jan 1991

• Softouch Guiding Catheter

  Class II

  FDA 510(k) K905547 Active Cleared 5 Feb 1991

• Mallard Medical Model 2400 Anesthesia Ventilator

  Class II

  FDA 510(k) K902405 Active Cleared 4 Mar 1991

• Hygrobac, S Hygroboy and Hygrobaby Open recall

  Class II

  FDA 510(k) K941381 Active Cleared 15 Apr 1994

• Softtouch(R) Guiding Catheter

  Class II

  FDA 510(k) K912199 Active Cleared 30 Jul 1991

• Sealguard Evac Endotracheal and Endotracheal Tubes

  Class II

  FDA 510(k) K082520 Active Cleared 2 Oct 2008

See all devices from Mallinckrodt Medical →