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Ohio Legal Updates

SAPIEN 3 Ultra Delivery System Recalled over Concerns of Injury and Death

By Burg Simpson

heart valve surgery sapian 3 transcatheter aortic replacement

On August 22, 2019, the FDA reported that Edward Lifesciences, LLC recalled its SAPIEN 3 Ultra Delivery System due to reports of burst balloons during transcatheter aortic valve replacement surgery. Transcatheter aortic valve replacement surgery is a minimally invasive procedure where the aortic valve is replaced using a catheter- a thin tube inserted into the… Read more »

Infant Warmers Urgently Recalled due to Falling Risk

By Heidi Culbertson

Baby

Infant Warmers Urgently Recalled due to Falling Risk On July 12, 2019, the U.S. Food and Drug Administration (“FDA”) announced the Class I recall of GE Healthcare’s Giraffe and Panda i-Res Infant Warmers after GE received reports of infants suffering injuries, including fractured skulls, associated with the warmers. A Class I recall is the FDA’s… Read more »

Millions of Medical Device Injuries and Malfunctions Hidden from the Public

By Heidi Culbertson

Medical Devices

By Jessica L. Powell, Burg Simpson Associate Millions of Medical Device Injuries and Malfunctions Hidden from the Public  5.7 million reports of device injuries and malfunctions were hidden from the public, according to Kaiser Health News. Medical device manufacturers are required to notify the FDA about certain device injuries and malfunctions, called “adverse events.” Generally,… Read more »

Multiple Drops/Medications for the Eyes Recalled due to Sterility Concerns

By Burg Simpson

On July 3, 2019, the FDA announced that Altaire Pharmaceuticals voluntarily recalled certain eye drops, eye lubricants, and prescription eye ointments sold over the counter under the Walgreens brand name, as well as some prescription products. According to the FDA, Altaire initiated the recall “due to management concerns regarding the sufficiency of Quality Assurance controls… Read more »

Recall of IntraClude Device Used In Patients Undergoing Cardiopulmonary Bypass

By Burg Simpson

Cardio Image

By Melanie S. Bailey, Burg Simpson Shareholder Recall of IntraClude Device Used In Patients Undergoing Cardiopulmonary Bypass Edwards Lifesciences has issued a Class I recall of its IntraClude Intra-Aortic Occlusion Device used in patients undergoing cardiopulmonary bypass.  Cardiopulmonary bypass machines are used to temporarily take over the function of the heart and lungs during surgery. … Read more »

THE NATIONAL TRIAL LAWYERS NAMES JANET G. ABARAY TO THE “TOP 100 CIVIL PLAINTIFF TRIAL LAWYERS” IN OHIO

By Heidi Culbertson

Ohio Attorney Janet G Abaray hero image

THE NATIONAL TRIAL LAWYERS NAMES JANET G. ABARAY TO THE “TOP 100 CIVIL PLAINTIFF TRIAL LAWYERS” IN OHIO BURG SIMPSON CONGRATULATES JANET ABARAY! The National Trial Lawyers is pleased to announce that Janet G. Abarayof Burg Simpson in Cincinnati has been selected for inclusion into its Top 100 Civil Plaintiff Trial Lawyers in Ohio, an honor given to only a… Read more »

Hudson RCI® Sheridan® Endotracheal Tubes Recalled After Reports of 4 Deaths associated with Use of the Products.

By Burg Simpson

Hudson RCI® Sheridan® endotracheal tubes Recalled After Reports of 4 Deaths associated with Use of the Products. On June 25, 2019, the FDA announced that Teleflex Incorporated has recalled some of its Hudson RCI® Sheridan® endotracheal tubes following reports of several deaths and serious injuries. Endotracheal tubes are used to help patients breathe when they… Read more »

Balloon Catheter Recalled due to Bursting.

By Burg Simpson

Balloon Catheter Recalled due to Bursting. On June 18, 2019, the FDA reported that Cook Incorporated has recalled a balloon catheter, the Advance Enforcer 35 Focal-Force PTA Balloon Catheter 6mm x 4cm.  This catheter is used to open blocked or narrowed arteries that supply blood to the leg. What are balloon catheters? Balloon catheters are… Read more »

The Janet Abaray Scholarship Fund Supports Students at the University of Cincinnati.

By Heidi Culbertson

Ohio Attorney Janet G Abaray

The Janet Abaray Scholarship Fund Supports Students at the University of Cincinnati. Janet Gilligan Abaray, the managing partner of Burg Simpson Ohio, has been donating personally to the College of Arts and Sciences at the University of Cincinnati since 2012.  The funds are dedicated to the English Department, which allocates the donation as a scholarship… Read more »

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