MB: Teleflex Medical is recalling some of the company's AQUA+FLEX Hygroscopic Condenser Humidifiers. These devices are passive humidifiers used during mechanical ventilation to warm and humidify inspired gas.
AR: The company has received complaints that the flextube connector may not fit securely inside the endotracheal tube connector, and that could cause these components to come apart. That should trigger an alarm from the ventilator, the oxygen sensor or other devices connected to the AQUA+FLEX tubing. But if the alarm isn't responded to promptly, a disconnected tube could lead to serious injury or death in ventilator-dependent patients.
MB: The recall affects AQUA+FLEX humidifiers that were manufactured between March 2 and December 14, 2009. Check our website for the specific lot numbers. Anyone who has the recalled devices should not use them and contact Teleflex Medical at 866-246-6990.

标题
AQUA+FLEX Humidifier Recall (FDA)

视频介绍
FDA Patient Safety News - June, 2010 - Show #99
Teleflex Medical is recalling some of the company's AQUA+FLEX Hygroscopic Condenser Humidifiers.

Speaker #1: Mark Barnett (MB), Assistant Director, Education & Communication, U.S. Food and Drug Administration

Speaker #2: Anita Rayner (AR), Associate Director, Policy & Communications, U.S. Food and Drug Administration