Teleflex Medical Incorporated manufactures and markets critical care, respiratory care, anesthesia, and surgical instruments and devices in the United States and internationally. It offers surgical instruments and devices, cardiac devices, and other specialty products. The company also provides central venous access catheters, respiratory products, anesthesia products, urological catheters, surgical solutions and aids, and left heart products. The company’s products include dialysis catheters, declotting devices, micro-inducers, arterial lines, and ultrasound products; aerosol delivery products, oxygen therapy products, humidification products, filtration products, ventilation supplies, ince...
2917 Weck Drive
Research Triangle Park
Durham, NC 27709
Founded in 1945
Teleflex Medical Announces Worldwide Voluntary Recall of ISIS(TM) HVT(TM) Tracheal Tube Cuffed with Subglottic Secretion Suction Port
Feb 12 14
Teleflex Medical Incorporated has announced a worldwide voluntary recall of its ISIS(TM) HVT(TM) 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.