News Details

WAYNE, Pa.--(BUSINESS WIRE)--Sep. 8, 2015-- Teleflex Incorporated (NYSE: TFX) announced today that the U.S. Food and Drug Administration (FDA) has classified the voluntary medical device recall of HUDSON RCI® SHERIDAN SHER-I-BRONCH® Endobronchial Tube as a Class 1 recall. FDA defines Class I recalls as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

Teleflex is recalling the products referenced above following receipt of customer complaints reporting that the double swivel connector may crack or separate on the endobronchial tube. Should this occur, the device may leak, causing a risk of respiratory distress or hypoxia that can, in some cases, lead to the need to re-intubate the patient. There have been no reports of patient injury as a result of this issue.

Teleflex notified both domestic and foreign hospitals and distributors via an Urgent Medical Device recall letter dated June 1, 2015. This recall involves the retrieval of unused product in the field.

At the time of the recall, there were 78 complaints of this issue. Two-hundred thirty-three (233) lots across twelve (12) product codes are affected by this recall for a total of 188,195 units distributed to the field. See table below for affected product codes. A full list of affected lot numbers can be found in the appendix to this notification.

The original recall notice can be found at Teleflex’s website:

http://www.teleflex.com/en/recall/Sheribronch%201st%20Customer%20Notification.pdf

Consumers with questions may contact the company at 1-866-246-6990; 8am to 8pm, ET, Monday through Friday.

Any adverse reactions experienced with the use of this product, and/or quality problems can also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

About Teleflex Incorporated

Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Teleflex is the home of Arrow^®, Deknatel^®, Hudson RCI^®, LMA^®, Pilling^®, Rusch^® and Weck^® – trusted brands united by a common sense of purpose.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.

View source version on businesswire.com: http://www.businesswire.com/news/home/20150908005205/en/

Source: Teleflex Incorporated

Teleflex Incorporated
Jake Elguicze
Treasurer and Vice President, Investor Relations
610-948-2836