Sheridan/Hvt, Cf, Uncuffed

• 8 recalls, same reason

  • Terminated Z-2313-2019 FDA Class I ·initiated 30 Jul 2019
  • Terminated Z-2315-2019 FDA Class I ·initiated 30 Jul 2019
  • Terminated Z-2316-2019 FDA Class I ·initiated 30 Jul 2019
  • Terminated Z-2317-2019 FDA Class I ·initiated 30 Jul 2019
  • Terminated Z-2314-2019 FDA Class I ·initiated 30 Jul 2019
  • Terminated Z-2318-2019 FDA Class I ·initiated 30 Jul 2019
  • Terminated Z-2312-2019 FDA Class I ·initiated 30 Jul 2019
  • Terminated Z-2311-2019 FDA Class I ·initiated 30 Jul 2019

  Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

• • Terminated Z-1956-2019 FDA Class I ·initiated 7 Jun 2019

  Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming disconnected from Endotracheal Tube.

• 8 recalls, same reason

  • Terminated Z-1766-2019 FDA Class I ·initiated 24 May 2019
  • Terminated Z-1761-2019 FDA Class I ·initiated 24 May 2019
  • Terminated Z-1762-2019 FDA Class I ·initiated 24 May 2019
  • Terminated Z-1763-2019 FDA Class I ·initiated 24 May 2019
  • Terminated Z-1760-2019 FDA Class I ·initiated 24 May 2019
  • Terminated Z-1759-2019 FDA Class I ·initiated 24 May 2019
  • Terminated Z-1764-2019 FDA Class I ·initiated 24 May 2019
  • Terminated Z-1765-2019 FDA Class I ·initiated 24 May 2019

  This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.

• • Terminated Z-1177-2017 FDA Class II ·initiated 18 Oct 2016

  Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube.

• • Terminated Z-1938-2016 FDA Class II ·initiated 5 May 2016

  The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.

• • Terminated Z-1078-2015 FDA Class II ·initiated 9 Jan 2015

  Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube.

• • Terminated Z-0799-2015 FDA Class II ·initiated 12 Nov 2014

  Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube.

• 2 recalls, same reason

  • Terminated Z-1891-2009 FDA Unclassified (pre-2012) ·initiated 6 Jul 2009
  • Terminated Z-1890-2009 FDA Unclassified (pre-2012) ·initiated 6 Jul 2009

  The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings.

• 3 recalls, same reason

  • Terminated Z-0127-2007 FDA Unclassified (pre-2012) ·initiated 27 Sep 2006
  • Terminated Z-0128-2007 FDA Unclassified (pre-2012) ·initiated 27 Sep 2006
  • Terminated Z-0126-2007 FDA Unclassified (pre-2012) ·initiated 27 Sep 2006

  Biological indicator failed. Investigation eliminated all equipment and product related factors.

• • Terminated Z-0582-05 FDA Unclassified (pre-2012) ·initiated 14 Jan 2005

  Some of the primary labels have the internal diameter (ID) and outer diameter (OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID 8.0 and OD 10.9 mm, mislabeling the size of the tracheal tube.

510(k) Number

K822082 ↗

FDA Product Code

BTR

Device Class

Class II

Regulation

21 CFR Part 868.5730

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Endotracheal Tube, Accessory

  Class II

  FDA 510(k) K862347 Active Cleared 11 Jul 1986

• Lazer-Trach Tracheal Tube

  Class II

  FDA 510(k) K922894 Active Cleared 7 May 1993

• Introduction/Drainage Catheter & Access

  Class I

  FDA 510(k) K881873 Active Cleared 18 May 1988

• Clinical Electronic Thermometers

  Class II

  FDA 510(k) K882127 Active Cleared 4 Aug 1988

• Ndyag Laser Tracheal Tube

  Class II

  FDA 510(k) K880960 Active Cleared 29 Apr 1988

• Tracheal/Bronchial Differential Ventilation Tube

  Class II

  FDA 510(k) K851856 Active Cleared 23 May 1985

See all devices from Sheridan Catheter Corp. →