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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Teleflex Inc | NYSE:TFX | NYSE | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
4.28 | 2.15% | 203.01 | 206.515 | 199.12 | 201.19 | 602,920 | 23:42:55 |
Vascular Solutions, Inc. voluntarily initiates a worldwide recall of Venture Catheters on April 25, 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 5820Refer to appendix for all line items
5821 5822Consumers 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 CathetersAffected 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
View source version on businesswire.com: http://www.businesswire.com/news/home/20170622005799/en/
Teleflex IncorporatedJake ElguiczeTreasurer and Vice President, Investor Relations610-948-2836
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