Teleflex Medical Announces Worldwide Voluntary Recall of ISIS™ HVT™ Tracheal Tube Cuffed with Subglottic Secretion Suctio...
February 12 2014 - 4:00PM
Business Wire
Teleflex Medical Incorporated has announced a worldwide
voluntary recall of its ISIS™ HVT™ Tracheal Tube Cuffed with
Subglottic Secretion Suction Port (with and without Preloaded
Stylet). This recall is being conducted because of complaints that
the tracheal tube can kink during patient use. If a tracheal tube
kinks, it can deprive the patient of adequate ventilation causing
serious injury, including hypoxic injury and/or anoxia.
The U.S. Food and Drug Administration (“FDA”) has classified
this action as a Class I recall. FDA defines class I recalls as “a
situation in which there is a reasonable probability that the use
of or exposure to a violative product will cause serious adverse
health consequences or death.”
Teleflex initiated this recall by a letter to its U.S. customers
on January 6, 2014. In accordance with the instructions provided in
the recall letter, customers should immediately discontinue use of
the recalled devices and return all unused ISIS products to
Teleflex Medical. The affected product codes are:
Product
Description Product Code
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction
Port, 6.0 5-13012 ISIS HVT Tracheal
Tube Cuffed with Subglottic Secretion Suction Port, 6.5
5-13013 ISIS HVT Tracheal Tube Cuffed with
Subglottic Secretion Suction Port, 7.0
5-13014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion
Suction Port, 7.5 5-13015 ISIS HVT
Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0
5-13016 ISIS HVT Tracheal Tube Cuffed
with Subglottic Secretion Suction Port, 8.5
5-13017 ISIS HVT Tracheal Tube Cuffed with Subglottic
Secretion Suction Port, 9.0 5-13018
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction
Port and Preloaded Stylet, 6.0 5-14012
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction
Port and Preloaded Stylet, 6.5 5-14013
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction
Port and Preloaded Stylet, 7.0 5-14014
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction
Port and Preloaded Stylet, 7.5 5-14015
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction
Port and Preloaded Stylet, 8.0 5-14016
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction
Port and Preloaded Stylet, 8.5 5-14017
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction
Port and Preloaded Stylet, 9.0 5-14018
A list of product and lot numbers affected by this recall, as
well as the original recall notice, can be found at Teleflex’s
website:
Recall Notice
Consumers with questions may contact the company at
1-866-804-9881; 8am to 8pm, ET, Monday through Friday.
Any adverse reactions experienced with the use of these
products, and/or quality problems may also be reported to the FDA’s
MedWatch Program by phone at 1-800-FDA-1088, by Fax at
1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane,
Rockville, MD 20852-9787, or on the MedWatch website at
www.fda.gov/medwatch.
About Teleflex Medical Incorporated
Teleflex Medical Incorporated is a subsidiary of Teleflex
Incorporated (NYSE:TFX). Teleflex Incorporated is a leading global
provider of specialty medical devices for a range of procedures in
critical care and surgery. Our mission is to provide solutions that
enable healthcare providers to improve outcomes and enhance patient
and provider safety. Headquartered in Limerick, PA, Teleflex
employs approximately 11,400 people worldwide and serves healthcare
providers in more than 140 countries. For additional information
about Teleflex please refer to www.teleflex.com.
Teleflex Medical IncorporatedJake ElguiczeTreasurer and Vice
President, Investor Relations610-948-2836
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