Devices

Broselow Pediatric Emergency Rainbow Tape Recall

AirLife is recalling certain lots of its Broselow Pediatric Emergency Rainbow Tape because they were manufactured with incorrect information on the tape. “Incorrect joules in the cardioversion and defibrillation section are printed in the red zone of the tape,” a recall notice says. “Using the incorrect information in this section for cardioversion and defibrillation could lead to shocking a patient with an excessive dose of joules, causing potential significant harm including burns, heart damage, and cardiac arrest.” There is also incorrect sodium bicarbonate concentration information printed in the orange and grey zones of the tape. To date, AirLife says it has not received any reports of serious injuries or deaths associated with the issue.

The tape is a color-coded length-based tape measure that provides information about a child’s height. Its color zones provide pre-calculated information for medication dosages, equipment sizes, and other relevant emergency procedures to reduce the time needed to calculate these in a critical emergency, according to the notice.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome