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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Teleflex Medical Announces Worldwide Voluntary Recall of Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570)

 

Company Contact:
Jake Elguicze, 
Vice President Investor Relations
Tel: 610-948-2836

 

FOR IMMEDIATE RELEASE - May 6, 2010 - Research Triangle Park, NC – Teleflex Medical has announced a worldwide voluntary recall initiated on March 19, 2010, affecting certain lot numbers of the Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (HCH) (catalog number 1570) a passive humidifier indicated for use to effectively warm and humidify inspired gas during mechanical ventilation. 

The company 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 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 United States Food and Drug Administration (FDA) and other authorities of this recall. The product was distributed to hospitals and distributors in the United States and Japan and may be used in healthcare facilities or in home health care. 

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: 

Lot Numbers:

200910 200911 200913 200914
200916 200919 200920 200921
200927 200928 200929 200930
200940 200941 200942 200943
200945 200948 200951

Lot numbers are clearly printed on the individual product packaging. Catalog number 1570 is displayed on the product’s instructions for use.

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.

Teleflex Medical is committed to providing high quality, safe and effective products. Any adverse events experienced with the use of this product, and/or quality problems can also be reported to the FDA’s MedWatch Adverse Event Reporting program by telephone at 1-800-FDA-1088 or online by visiting the FDA website at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm and following the instructions for submitting the appropriate forms electronically or by mail.

Teleflex Medical is the largest business segment of Teleflex Incorporated. Neither the costs anticipated with the recall, nor the impact on Teleflex Medical’s business, are expected to be material to Teleflex.

About Teleflex

Teleflex Incorporated is a global medical device company with niche businesses serving aerospace and commercial markets. Teleflex Medical, the company's largest business segment, designs, manufactures and distributes medical devices for critical care and surgical applications serving customers in more than 140 countries. The company is focused on medical device technology that enables healthcare providers to improve outcomes, reduce infections and improve patient and provider safety. Additional information about Teleflex Incorporated can be obtained from the company's website at www.teleflex.com.

 

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