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).
Teleflex’s recall is being conducted because of complaints that the tracheal tube can kink during patient use. The consequence of a tracheal tube kink is that the patient could be deprived of adequate ventilation causing serious injury, including hypoxic injury and/or anoxia.
The U.S. 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 have been instructed to immediately discontinue use of the recalled devices and return all unused ISIS products to Teleflex Medical.
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 here.
Source: Teleflex Medical, Inc., Business Wire