Teleflex Medical Inc. issued a voluntary global recall of its AQUA+FLEX humidifier after receiving complaints that a component of the device may disconnect.
The Everett, Mass.-based company yesterday issued a statement through the Food & Drug Administration’s website detailing a recall for a device. The company said it has "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. Device failure is recognizable 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 related to the potential malfunction have been reported, but the problem could lead to serious injury or death if there is no response to the alarm.
Teleflex recommended that users discontinue use of any products manufactured between March 2, 2009, and Dec. 14, 2009. The lot numbers affected are 200910, 200911, 200913, 200914, 200916, 200919, 200920, 200921, 200927, 200928, 200929, 200930, 200940, 200941, 200942, 200943, 200945, 200948, 200951.
