Recalls: One down for Teleflex, one up for Masimo

August 8, 2011 By MassDevice staff Leave a Comment

Masimo Corp. (NDSQ:MASI) notched a win by reversing a voluntary recall of its noninvasive finger sensors while Teleflex Inc. (NYSE:TFX) subsidiary Arrow International continues to butt heads with the FDA.

Just months after Teleflex announced that Arrow had resolved all outstanding issues cited in a FDA Warning Letter regarding quality control issues, the watchdog agency has bumped up Arrow’s NextStep hemodialysis catheter recall to a Class I, a ranking reserved for products that could cause serious injury or death.

That Warning Letter was sent in October 2007, just weeks after Limerick, Pa.-based Teleflex, which ranked 39th on the MassDevice Big 100 list of the world’s largest medical device companies, completed its acquisition of Arrow, and took nearly four years to clear up.

The recent recall comes on concerns of breaking and separation of the stylet within the catheters, which are used for long-term access in adult patients needing hemodialysis or apheresis treatment.

The NextStep catheters were distributed in California, Delaware, Florida, Michigan, North Carolina and Tennessee, according to the FDA’s recall website.

Meanwhile Masimo, which ranked 86th on the MassDevice Big 100, reversed a voluntary recall on finger sensors used with its Pronto-7 handheld device, and announced that it will launch the product internationally.

The sensors had been recalled due to performance problems in low ambient temperatures, which the company has resolved. The device and its finger sensor are pending FDA 510(k) clearance, according to a press release.

Health Canada implements electronic medical device clinical trial data submission
By Stewart Eisenhart, Emergo Group Health Canada, Canada’s medical device market regulator, has begun accepting some clinical trial-related information from sponsors via electronic submissions. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its… […]
This company’s medical containment system played a role in a coronavirus evacuation
The Containerized Bio-Containment System (CBCS), developed by Kansas City-based MRIGlobal, is a first-of-its-kind, flyable medical transport unit and features full biocontainment. This past week, the CBCS was brought into the ongoing worldwide coronavirus outbreak. Get the full story on our WTWH Media sister site R&D World. The post This company’s medical containment system played a […]
Zeiss expands its portfolio of microscope cameras
Zeiss recently announced that it has added four new CMOS cameras for digital imaging in light microscopy. These cameras are part of the Oberkochen, Germany-based company’s Axiocam series. The Axiocam 705 color and 712 color are designed to deliver the best possible image quality for histology, pathology or material research and analysis, thanks to excellent… […]
FDA recommends limiting use of power morcellators
The FDA today recommended that laparoscopic power morcellators, which have been implicated in the spread of cancer, be limited to use with certain tissue containment systems and only in premenopausal women under 50 years of age. Power morcellators were used for 20 years to laparoscopically remove benign tumors of the uterus, known as fibroids, by… […]
Abilitech aims to arm people with independence
Some have dubbed Abilitech’s device “a wheelchair for the arms.” Its machined aluminum exoskeletal arm and breathable cloth vest use a spring counterbalance system and a “living hinge” that spreads the load, making it — and the arm — feel weightless. Nancy Crotti, Managing Editor Rob Wudlick brushed his teeth on his own recently for… […]
RJG Germany opens injection molding training facility
RJG Germany (Karlstein) recently opened a new training lab for injection molding. The facility consists of a classroom that seats up to 20 students and a fully equipped lab for hands-on experience. The technical center currently consists of a 60-ton injection molding machine from Yizumi Germany, temperature control units and a material drying system from… […]
Instron debuts two new universal testing systems
Instron (Norwood, Mass.) announced today that it is introducing a new generation of universal testing systems. The 3400 and 6800 Series are successors to the company’s 3300 and 5900 Series systems and are available in single- and dual-column models with capacities ranging from 500 N to 50 kN. Instron said it has added features and… […]
Medical tubing market to be worth $12 billion in 2025
The medical tubing market is expected to be worth $11.9 billion by 2025, according to an analysis from Grand View Research. Grand View Research suggests the industry will expand at a revenue-based consumer annual growth rate of 9.2% over the next five years. Increased health expenditures from individuals and increased emphasis on healthcare by the […]
How diaphragm pumps can work for sensitive devices
Diaphragm pumps work like bicycle pumps, with one intake and one output cycle per revolution of the drive motor, which produces an inherently pulsatile flow. Dynaflo developed one for the U.S. military that virtually eliminates this effect. Lorenzo Majno, Dynaflo Diaphragm pumps offer a number of features that could be valuable to designers of products… […]
MTD Micro Molding late president to be inducted into Plastics Hall of Fame
MTD Micro Molding this week announced that its late president, Dennis Tully, will be inducted into the Plastics Academy’s Plastics Hall of Fame. Tully is one of this year’s six posthumous inductees, who are elected by living members of the Hall of Fame following a screening process. “These new posthumous inductees proudly represent the length… […]
This neural implant can be both remotely charged and programmed
Engineers at Rice University’s Brown School of Engineering are touting the first neural implant capable of being programmed and charged remotely with a magnetic field. Kaiyuan Yang, Jacob Robinson, Zhanghao Yu and Joshua Chen collaborated to develop the integrated MagNI (magnetoelectric neural implant) microsystem, which could allow imbedded devices such as a spinal cord stimulator… […]