teleflex inc (TFX) Key Developments
Teleflex Incorporated Receives FDA Market Clearance for its ARROW Endurance™ Extended Dwell Peripheral Catheter System
Jul 29 15
Teleflex Incorporated announced that its ARROW Endurance™ Extended Dwell Peripheral Catheter System received market clearance from the U.S. Food and Drug Administration (FDA). The new device is a peripheral catheter systm in which the catheter is cleared by the FDA to dwell up to 29 days. The extended dwell catheter enables hospitals to avoid using multiple PIVs to achieve longer dwell times while also avoiding the extra clinical risks and expenses associated with a peripherally inserted central catheter (PICC). The intravascular catheter is intended for short-term use (up to 29 days) to permit delivery of infusion therapies, pressure monitoring, high pressure injection (325 psi max.), and withdrawal of blood. Designed to maximize performance and ease-of-use, the extended dwell system is engineered to increase safety for clinicians and reduce needle sticks for patients. The device contains a passive needle safety that reduces the risk of accidental needle stick injuries and exposure to blood. The closed system design makes it less likely that clinicians will accidentally come in contact with bloodborne pathogens. Teleflex expects to launch the ARROW Endurance™ Extended Dwell Peripheral Catheter System in the United States later in 2015.
Teleflex Incorporated Announces Worldwide Voluntary Recall of Hudson RCI® LIFESAVER® Neonate Manual Resuscitator
Jun 29 15
Teleflex Incorporated announced that the U.S. Food and Drug Administration (FDA) has classified the voluntary medical device recall of Hudson RCI® LIFESAVER® Neonate Manual Resuscitator 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 because the intake port may be blocked, which can cause the bag to fail to fill. No patient injury or harm has been reported, however, a delay in treatment may occur while another resuscitator is obtained. A delay in treatment may potentially lead to adverse consequences such as hypoxia. Teleflex notified both domestic and foreign hospitals and distributors via an Urgent Medical Device recall letter dated May 14, 2015. This recall involves the retrieval of unused product in the field.
Teleflex Wins Multiple Awardees Contract Award from NHS London Procurement Partnership for Total Cardiology Solutions
Jun 9 15
Teleflex has won a zero pound multiple awardees contract award from NHS London Procurement Partnership for total cardiology solutions (Interventional Radiology Products used in Cardiology). No contract amount was specified (GBP 0).
Teleflex Incorporated Redeems $250,000,000 Outstanding Principal Amount of its 6.875% Senior Subordinated Notes Due 2019
Jun 3 15
On June 1, 2015 Teleflex Incorporated redeemed $250,000,000 outstanding principal amount of its 6.875% Senior Subordinated Notes due 2019 using borrowings under the Company's revolving credit agreement and securitization facility and cash on hand. The Redeemed Notes were redeemed at a redemption price equal to 103.438% of the principal amount thereof, plus accrued and unpaid interest to, but not including, the Redemption Date.
Teleflex Incorporated Presents at William Blair’s 35th Annual Growth Stock Conference, Jun-10-2015 02:00 PM
May 27 15
Teleflex Incorporated Presents at William Blair’s 35th Annual Growth Stock Conference, Jun-10-2015 02:00 PM. Venue: Four Seasons Hotel, Chicago, Illinois, United States. Speakers: Thomas E. Powell, Chief Financial Officer and Executive Vice President.