Devices

Hamilton Recalls Defective Coaxial Breathing Sets

Hamilton Medical is recalling (Class 1) certain lots of coaxial breathing sets due to a quality issue involving a defective blade in the tube-cutting stage of production that may lead to a crack in the inner blue limb of the circuit. “The inner blue limb delivers fresh gas to the patient while the outer limb carries away exhaled gas,” a recall notice says, adding that if a leakage occurs from a crack in this limb, then separation between inspiratory and expiratory flows becomes compromised. This could lead to the partial or complete rebreathing of exhaled gases, the notice says.

Using affected products may cause serious adverse health consequences, including acute buildup of carbon dioxide (hypercapnia) that the body can’t remove (respiratory acidosis), according to the notice. “If the problem goes unrecognized, it may cause organ dysfunction and death,” it says. To date, there have been no reported injuries or deaths related to this issue.

The breathing circuits are intended to connect Hamilton-C1/T1/MR1 ventilators to a patient tube or respiratory mask during ventilation.

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