FDA announces Class 1 recall for Draeger breathing filters
Editor's Note The FDA has issued a Class 1 recall—the most severe category indicating risk of serious injury or death—for Draeger Filter SafeStar 90 Plus (MP05785), Filter SafeStar 55 Plus (MP05790), Filter SafeStar 60A Plus (MP05795), and Filter/HME TwinStar HEPA Plus (MP05801) breathing system filters, affecting all lot numbers. Draeger…
Soap recalled due to to bacterial contamination
Editor's Note DermaRite Industries has voluntarily recalled multiple lots of healthcare products nationwide due to contamination with Burkholderia cepacia, a bacterium that poses serious infection risks to immunocompromised individuals, according to an August 10 article in Newsweek. The recall affects four product lines commonly used in healthcare settings for handwashing…
FDA orders opioid label changes to highlight long-term risks
Editor's Note The US Food and Drug Administration (FDA) is requiring safety labeling changes for all opioid pain medications to better emphasize and explain the risks associated with long-term use, according to a July 31 announcement. These changes follow a May advisory committee meeting where the agency reviewed data on…
FDA safety alerts flag cardiac devices
Editor's Note The US Food and Drug Administration (FDA) issued early alerts August 6 for three medical devices due to safety concerns: Medline ReNewal’s reprocessed St. Jude Medical electrophysiology catheters, Boston Scientific’s ENDOTAK RELIANCE defibrillation leads with ePTFE-coated coils, and Boston Scientific's WATCHMAN Access Systems. The Medline alert involves specific lots…
FDA issues Class I recall for Philips BiPAP ventilators
Editor's Note Philips Respironics BiPAP A30, A40, and V30 Auto ventilators are subject to a Class 1 recall—the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death—due to the risk for a failure in the Ventilator Inoperative alarm, which can cause therapy interruption…
Cosmetic surgery chains targeted in lawsuits over disfiguring injuries, deaths
Editor's Note A growing subset of cosmetic surgery chains, some backed by private equity, have been named in multiple lawsuits alleging serious patient harm, according to an August 1 article in KFF Health News. Based on a joint investigation with NBC News, the outlets reports that chains offering body-reshaping operations…
Study: Postoperative delirium triples risk of complications, death in older patients
Editor's Note Postoperative delirium significantly worsens outcomes for older adults undergoing major noncardiac surgery, according to research published July 8 in JAMA Network Open. Specifically, findings showed patients who developed postoperative delirium had 3.5 times the odds of death or major complications, 2.8 times the odds of 30-day mortality, and…
FDA designates Class I recall for disposable surgical stapler cartridge correction
Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Ethicon Endo-Surgery, LLC’s Endopath Echelon Vascular White Reload for Advanced Placement Tip a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 25 announcement, the recall…
FDA designates Class I recall for arterial cannulae due to exposed wire risk
Editor's Note The US Food and Drug Administration (FDA) has designated a Class I recall—the most severe category indicating risk of serious injury or death—for several models of arterial cannulae manufactured by Edwards Lifesciences. Affected products include OptiSite Arterial Perfusion Cannula models OPTI16 and OPTI18, as well as Peripheral Femoral…
FDA designates Class I recall for mobile lift component
Editor's Note The US Food and Drug Administration (FDA) has designated Baxter’s recall of the Q-Link 13 mobile lift component a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 23 announcement, the optional component connects to sling bars on…
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