Drugs

Dräger Recalls Carina Ventilators

Drägerwerk has recalled its Dräger Carina Sub-Acute Care Ventilators due to the potential for contamination of the breathing gas with 1,3- Dichloropropan-2-ol, a constituent of the PE-PUR foam used for sound insulation. The company says testing “measured concentrations of 1,3-Dichloropropan- 2-ol above the acceptable uptake level during continuous use (more than 30 days) in pediatric patients.” To date, no complaints relating to this problem have been reported, it says.

Drägerwerk says the contamination was not discovered in biocompatibility tests conducted during product approvals and modifications. “In literature, 1,3-Dichloropropan-2-ol is considered to be acutely toxic and a potential carcinogen,” it says. “Potential risks of chemical exposure due to off-gassing include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects.”

Dräger stopped making the Carina ventilator in 2019, but says it is planning to remove the foam from Carina ventilators still in use and replace with a newly designed blower cover, without additional foam, for noise reduction purposes.

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