Devices

Datex-Ohmeda Air Compressor Recall is Class 1

FDA has classified as Class 1 a Datex-Ohmeda recall of its EVair 03 (Jun-air) air compressor (model numbers: 1609000 and 1609002) after the company says it became aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstrom Carestation/Pro ventilators, respectively.

“These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40 degrees C (104 degrees F), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen),” a recall notice says.

The company says the EVair and Jun-air compressors are optional ventilator accessories intended to provide an alternative source of air flow for patient support for use in clinical scenarios where wall air is unavailable.

The company says it is continuing to evaluate the root cause of the elevated levels.

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