Teleflex Medical Recalls Humidifiers

Teleflex Medical has issued a recall of <"">AQUA+FLEX Hygroscopic Condenser Humidifiers (HCH) (catalog number 1570). According to the recall notice, Teleflex Medical 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.

The Teleflex Medical AQUA+FLEX HCH is a passive humidifier indicated for use to effectively warm and humidify inspired gas during mechanical ventilation. The product was distributed to hospitals and distributors in the United States and Japan and may be used in healthcare facilities or for in-home care.

Device failure is recognizable 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 U.S. Food and Drug Administration (FDA) and other authorities of this recall. Customers who have this product manufactured between March 2, 2009 and December 14, 2009, with the affected lot numbers should discontinue use. A list of lot numbers included in the recall can be found here.

Customers in the U.S. with questions can contact Teleflex Medical U.S. customer service at 866-246-6990 between the hours of 8am and 7pm, ET, Monday through Friday. Customers in Japan should contact Teleflex Medical International customer service at 919-361-3964.

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