Teleflex Resolves FDA Corporate Warning Letter

LIMERICK, Pa.--(BUSINESS WIRE)-- Teleflex Incorporated (NYSE:TFX), a global provider of medical technology products, announced today that it has received formal notification that it has successfully resolved all outstanding issues raised by the U.S. Food and Drug Administration (FDA) in a corporate Warning Letter received by its subsidiary, Arrow International (Arrow). The Warning Letter was received in October of 2007, and identified FDA’s observations on a variety of Arrow’s quality systems control measures that occurred prior to Teleflex’s acquisition of Arrow. The FDA notified the Company that its response and the actions that have been adopted and implemented have sufficiently addressed the FDA’s observations.

“Upon receiving the Warning Letter shortly after our acquisition of Arrow, our organization immediately went to work to address the FDA’s observations,” said Benson Smith, Chairman, President & CEO. “One of our key initiatives at Teleflex is to employ best practices throughout our operations. In the process of responding to the Warning Letter, we applied our standards to the entire Arrow organization. Today, the resolution of this issue represents the successful execution of our response to the Agency and illustrates our commitment to ensuring that our systems and procedures across all of our global facilities continue to provide the highest quality medical products for critical care procedures and surgery. The investments we have made, and will continue to make, will ensure the continuous improvement of our processes and products.”

About Teleflex Incorporated

Teleflex is a leading global provider of specialty medical devices for a range of procedures in critical care and surgery. Our mission is to provide solutions that enable healthcare providers to improve outcomes and enhance patient and provider safety. Headquartered in Limerick, PA, Teleflex employs approximately 12,000 people worldwide and serves healthcare providers in more than 130 countries. For additional information about Teleflex please refer to www.teleflex.com.

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.



CONTACT:

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

KEYWORDS:   United States  North America  Pennsylvania

INDUSTRY KEYWORDS:   Surgery  Health  Medical Devices  Other Health  FDA

MEDIA:

Logo
 Logo

Suggested Articles

The profit margins and management of Community Health Group raise questions about oversight of managed care insurers.

Financial experts are warning practices about the pitfalls of promoting medical credit cards to their patients.

A proposed rule issued by HHS on Tuesday would expand short-term coverage, a move Seema Verma said will have "virtually no impact" on ACA premiums.