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Teleflex’s (TFX) Vascular Solutions, Inc. Issues Recall of Venture® Catheters

Vascular Solutions, Inc. voluntarily initiates a worldwide recall of Venture Catheters on April 25, 2017

WAYNE, Pa.--(BUSINESS WIRE)--Jun. 22, 2017-- Teleflex Incorporated (NYSE: TFX), announces a worldwide recall of Venture® Catheters was voluntarily initiated by its Vascular Solutions, Inc. subsidiary on April 25, 2017. Vascular Solutions, Inc. is the manufacturer of Venture Catheters, which are designed for use in catheterization procedures, to direct, steer, control, and support a guidewire to access discrete regions of the coronary and peripheral vasculature. Two versions may also be used for manual delivery of saline solution or diagnostic contrast agents.

The U.S. Food and Drug Administration (FDA) classified this as a Class I recall. The FDA defines Class I recall 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."

The worldwide recall affects 4,679 units distributed in the United States. All unexpired lots of the Rapid Exchange (RX), Over-the-Wire (OTW), and Coronary Sinus (CS) versions of the product have been recalled due to the potential for excess material to be present within the inner lumen of the distal catheter tip. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury. No serious injuries or death have been reported in association with this issue to date.

Vascular Solutions, Inc. initiated the recall through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. Healthcare facilities with affected Venture Catheters should remove the products from their inventory and return them to Vascular Solutions, Inc. The notification identified the specific unexpired lots subject to the recall and included instructions on how to return the affected products to Vascular Solutions, Inc.

Vascular Solutions, Inc. has notified the FDA of this action.

See table below for affected product codes. A full list of affected lot numbers can be found in the appendix to this notification.

PRODUCTS AFFECTED

         
Product Code       Lot
5820      

Refer to appendix for all line items

5821      
5822      
     

Consumers with questions may contact the company by phone at 1-888-240-6001 Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time or by email at customerservice@vasc.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

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.

Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rusch, Venture, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2017 Teleflex Incorporated. All rights reserved.

Vascular Solutions, Inc. Venture Catheters
Affected Product Codes and Lots

             
Product Code       Lot    
5820       582455    
5820       582588    
5820       583022    
5820       583409    
5820       584469    
5820       584470    
5820       585180    
5820       585458    
5820       585787    
5820       587035    
5820       587036    
5820       587775    
5820       588097    
5820       588098    
5820       588794    
5820       589885    
5820       589886    
5820       590172    
5820       590776    
5820       591196    
5820       591198    
5820       592080    
5820       592526    
5820       593080    
5820       593519    
5820       593720    
5820       594204    
5820       594421    
5820       595195    
5820       595418    
5820       597293    
5820       597771    
5820       597967    
5820       598903    
5820       599045    
5820       599466    
5820       599903    
5820       601745    
5820       603987    
5820       603988    
5820       603991    
5820       604500    
5821       581713    
5821       583410    
5821       584471    
5821       585459    
5821       586408    
5821       586972    
5821       587408    
5821       588099    
5821       589268    
5821       589754    
5821       590404    
5821       591197    
5821       592081    
5821       592924    
5821       593520    
5821       595196    
5821       595419    
5821       596020    
5821       597294    
5821       599650    
5821       601196    
5821       601746    
5821       602260    
5821       603990    
5821       604049    
5821       605617    
5822       588100    
5822       590562    
5822       597905    
5822       599777    
5822       604862    

Source: Teleflex Incorporated

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



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