Devices

FDA Recalls Saline Solution

Medline Industries is recalling (Class 1) its Hudson RCI Addipak unit dose vial, 0.9% full normal saline solution (Lot 3B085) due to sterility concerns. The affected lot passed sterility testing, but another lot within the same cleaning cycle (Lot 3B087) failed the testing, exposing the affected lot to potential contamination, according to a recall notice.

“The use of non-sterile saline may cause serious adverse health consequences including difficulty breathing, general discomfort, nausea, wheezing, and infection. Infection can lead to life-threatening sepsis, and death,” the notice says. There have been no reports of injuries or death associated with this issue.

The product is used during treatments such as inhalation and irrigation therapy. It may be used with a non-ventilatory nebulizer to clean the lungs or for tracheal irrigation.

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