Teleflex Humidifier Recall: Defective Tube Could Cause Injury, Death
A defective ventilator tube has led to the recall of 19 lots of medical humidifiers by Teleflex Medical. Problems with the Teleflex humidifiers could cause patients to become disconnected from ventilators, putting them at risk of injury or death.
The FDA announced the Teleflex humidifier recall on May 6, after the company notified it that the flex tubes on its AQUA+FLEX humidifiers may not connect properly to peripheral devices, such as ventilators or oxygen sensors.
The humidifiers have a 22cm connector on the flex tubes that do not appear to always fit securely with the endotracheal tube (ET) connector. If the tube becomes disconnected an alarm will sound, however if there is not a prompt response to the alarm, an injury or death could occur.
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The humidifiers are designed to warm and humidify air being supplied by a mechanical ventilator.
The recall affects all Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (HCH) (catalog number 1570) with the following lot numbers: 200910, 200911, 200913, 200914, 200916, 200919, 200920, 200921, 200927, 200928, 200929, 200930, 200940, 200941, 200942, 200943, 200945, 200948, and 200951. The lot codes are printed on the individual product packaging, and the catalog number is printed on the humidifiers’ instructions.
Customers with questions have been asked to contact Teleflex Medical U.S. customer service at (866)246-6990. Anyone who has experienced health problems due to this medical device are urged to contact the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch.
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