Teleflex Medical Inc. 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 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 Jan. 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:
Teleflex Medical, headquartered in Limerick, Pa., is a provider of specialty medical devices for a range of procedures in critical care and surgery.
Release Date: February 12, 2014
Source: Teleflex Medical Inc.
