Devices

Honeywell Recalls Eyewash Cartridge

Honeywell Safety Products is recalling its Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station after a supplier of the cartridge was found to be non-compliant with GMP requirements.

“Use of or exposure to the eyewash without seeking medical attention afterwards could result in a range of ocular infections such as bacterial keratitis or endophthalmitis,” a recall notice says. “Immunocompromised individuals, those sustaining ocular injuries that damage the corneal epithelium, and those sustaining penetrating ocular injuries are at higher risk of potential infection.” To date, Honeywell says it has not received any adverse event reports related to the issue.

The eyewash cartridge is used for flushing or irrigating the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination, the notice says.

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