Teleflex Medical has announced a worldwide voluntary recall affecting certain lot numbers of the AQUA+FLEX hygroscopic condenser humidifier, catalog number 1570. The product is a passive humidifier used to effectively warm and humidify inspired gas during mechanical ventilation.
The company received complaints that the 22 cm connector on the flex tube may not fit securely within the endotracheal tube connector, an FDA statement notes. 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 have been reported to date, but a disconnected tube in ventilator-dependent patients without prompt response could lead to serious injury or death. Teleflex has notified the FDA and other authorities of this recall. The product was distributed to hospitals and distributors in the U.S. and Japan.
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: 200910, 200911, 200913, 200914, 200916, 200919, 200920, 200921, 200927, 200928, 200929, 200930, 200940, 200941, 200942, 200943, 200945, 200948 and 200951.
- read the FDA statement