Teleflex Medical had initiated a worldwide voluntary recall on March 19, 2010, affecting certain lot numbers of the Teleflex Medical Aqua+Flex Hygroscopic Condenser Humidifier (HCH) (catalog number 1570) a passive humidifier indicated for use to effectively warm and humidify inspired gas during mechanical ventilation.
Teleflex Medical had received product complaints that the 22cm connector on the flex tube may not fit securely within the endotracheal tube (ET) connector. This may result in the product becoming disconnected from the patient ET tube.
Teleflex Medical said that the device failure is recognisable by the user as an alarm from the ventilator, oxygen sensor or other compatible device to which the AQUA+FLEX tubing is connected. No injuries have been reported to date. However, a disconnected tube in ventilator dependent patients without prompt response to the alarm could lead to serious injury or death.
Teleflex Medical has notified the FDA and other authorities of the recall. The product was distributed to hospitals and distributors in the United States and Japan and may be used in healthcare facilities or in home health care.
Consumers who have AQUA+ FLEX HCH catalog number 1570 product, manufactured between March 2, 2009 and December 14, 2009, with the following lot numbers should discontinue use of Lot numbers which include 200910, 200911, 200913, 200914, 200916, 200919, 200920, 200921, 200927, 200928, 200929, 200930, 200940, 200941, 200942, 200943, 200945, 200948 and 200951.
Teleflex Medical said that the lot numbers are clearly printed on the individual product packaging. Catalog number 1570 is displayed on the product’s instructions for use.
Teleflex Medical is the business segment of Teleflex Incorporated. The company said that neither the costs anticipated with the recall, nor the impact on Teleflex Medical’s business, are expected to be material to Teleflex.