Devices

AVID Medical Recalls Organ Recovery Bags

AVID Medical has recalled (Class 1 device correction) certain organ recovery and medical convenience kits, warning that continued use of a non-medical-grade component could lead to serious injury or death. According to an agency notice, AVID Medical identified that 24-by-30-inch poly bags included in certain Organ Recovery OR Packs and medical convenience kits are not made from medical-grade plastic and, in some cases, may not be sealed at the bottom. The compromised bags could fail to contain donor organs during recovery or transport.

AVID Medical has advised customers to immediately stop using the poly bags included in the affected kits, segregate and quarantine remaining inventory, and add prominent warning labels to ensure the bags are discarded and not used. Other components of the kits may continue to be used, the company said.

FDA said use of the non-medical-grade bags could increase the risk of post-transplant infection, organ failure, chemical exposure, and the need for additional medical interventions or repeat transplantation. Regulators also warned that compromised sterility or leakage could lead to sepsis, organ rejection, or transmission of infectious diseases to transplant recipients. Transplant procedures could also be delayed or cancelled if donor organs are damaged or contaminated.

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