Devices

Medline Convenience Kit Recall is Class 1

FDA says the 8/22 Medline recall of three models of sterile medicine convenience kits is Class 1. An agency notice says the company contacted five customers on 8/8, telling them to hold any kits in their possession. A formal recall notice followed on 8/22, the agency says.

The three models of kits support general surgery procedures in adults, orthopedic surgery procedures in adults, and general surgery procedures in pediatric patients.

The company recalled the kits due to mislabeling as sterile without completing the sterilization process, according to the notice. It says the convenience kits were manufactured at a Medline site and shipped directly to distribution centers rather than to the sterilization site. The affected lots were then released to a small number of customers, the notice says. “The use of affected product may cause serious adverse health consequences, including bloodstream infection, fevers, sepsis, and death,” FDA cautions. It says there have been no reported injuries or deaths related to the issue.

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