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 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 safety alert for Baxter Novum IQ large volume pumps
Editor's Note The US Food and Drug Administration (FDA) issued an early alert for Baxter’s Novum IQ Large Volume Pumps (Model 40700BAXUS) due to potential for underinfusion when transitioning from a flow rate to a higher flow rate (eg, rate change or bolus). According to the agency’s July 22…
FDA issues early alert for microbore extension sets
Editor's Note B Braun Medical is recommending certain microbore extension sets—single use, disposable, add-ons for infusion, injection, or aspiration—be removed from anywhere they are used or sold, according to a July 17 announcement from the US Food and Drug Administration (FDA). According to FDA’s early alert, the recall was motivated…
Rehab hospitals face scrutiny over safety, profits
Editor's Note Although for-profit rehab hospitals have become highly profitable, a recent KFF Health News report highlights serious safety violations, including patient deaths due to carbon monoxide poisoning, medication errors, and falls. Published July 15, the article delves into recent data and inspections of these facilities, particularly those run by…
FDA designates Class 1 recalls for aspiration catheter, infusion accessory, endotracheal tubes
Editor's Note The US Food and Drug Administration (FDA) has issued three Class I medical device recalls—the most severe category indicating risk of serious injury or death—for Q’Apel Medical Inc.’s HIPPO 072 Aspiration System and Cheetah catheter, Fresenius Kabi USA’s Blood Products Administration Set with 200 Micron Filter, and Medline…
FDA designates Class 1 recalls for intraoperative positioning guidewires, infusion pumps, dialysate
Editor's Note Centerline Biomedical’s recall of IOPS Guidewire ATW-2, Zyno Medical’s recall of Z-800 series infusion pumps, and Nipro’s recall of MedicaLyte Liquid Bycarbonate Concentrate have been designated by the US Food and Drug Administration (FDA) as Class 1, the most serious designation indicating risk of severe injury or death.…
FDA issues early alerts for intravascular catheters
Editor's Note The US Food and Drug Administration (FDA) warned of safety risks resulting from manufacturing issues with two varieties of intravascular catheter—Conavi Medical’s Novasight Hybrid line and BD’s PowerPICC intravascular devices—in separate early alerts April 18. In one reported incident, the sheath of a Novasight Hybrid catheter—a device used…
Healthgrades announces 2025 Patient Safety Excellence Award recipients
Editor's Note Recognizing hospitals that excel at providing top-quality care while preventing serious safety events, Healthgrades’ 2025 Patient Safety Excellence Awards distinguish 442 hospitals in 40 different states. Announced March 11, the awards are based on inpatient MedPAR data from 2021 to 2023. Recognized hospitals must meet clinical quality thresholds,…
FDA pilot program aims to expedite high-risk medical device recall communication
Editor's Note The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has initiated a pilot program to improve the speed of public notifications regarding high-risk medical device recalls. According to a November 21 announcement, this initiative aims to minimize the time between the FDA's awareness…
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