Tag: FDA Safety Alert

FDA warns of continued cardiac pump safety concerns after series of recalls

Editor's Note The US Food and Drug Administration (FDA) is urging healthcare providers to avoid using Getinge heart devices due to continued safety concerns that remain unaddressed despite previous recalls. Issued to healthcare providers May 8, the warning letter applies to Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices…

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By: Matt Danford
May 9, 2024
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Joint replacement manufacturer recalls products after FDA packaging warning

Editor's Note A January complaint about inefficient packaging for joint replacement products has prompted the manufacturer to recall certain knee and shoulder system devices after initially declining to take the products off the market, according to an April 23 report in Health Exec. The manufacturer, Exactech, is now recalling a…

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By: Matt Danford
April 25, 2024
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FDA updates warning about plastic syringes made in China

Editor's Note An ongoing US Food and Drug Administration (FDA) evaluation of plastic syringes made in China reveals that quality problems are more widespread than initially believed, the agency reported on March 19. The update to an original November 23 safety notice recommends the following action to alleviate potential quality…

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By: Matt Danford
March 20, 2024
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FDA issues warning on fraudulent, unreliable medical device testing data

Editor's Note The FDA has issued a warning regarding fraudulent, duplicated and otherwise unreliable data coming from third party test labs that produce data for medical device companies, including many based in India and China. Issued February 20, the alert warns medical device manufacturers that they are responsible for confirming the…

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By: Brita Belli
February 21, 2024
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FDA updates safety recall of certain saline, sterile water medical products

Editor's Note The US Food and Drug Administration (FDA) on January 24 updated its safety recall communication from November 6 to add to the voluntary recalls of saline and sterile water medical products associated with Nurse Assist, LLC. The FDA recall notice lists various water-based medical products manufactured by Nurse…

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By: Tarsilla Moura
January 31, 2024
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FDA safety alert targets shoulder implant packaging

Editor's Note: Equinoxe Shoulder System joint replacement devices manufactured by Exactech between 2004 and 2021 are at risk of premature wearing or failure due to defective packaging, according to a January 16 safety alert from the US Food and Drug Administration (FDA). The bags used to package the devices were…

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By: Matt Danford
January 23, 2024
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Superpotency concerns spur recall of IV bags for vancomycin, phenylephrine, and fentanyl

Editor's Note:  Englewood, Colo,-based Leiters Health is voluntarily recalling 33 lots of vancomycin, phenylephrine, and fentanyl IV bags due to concerns that they may contain twice the labeled amount of drug, according to a January 8 safety alert from the US Food and Drug Administration (FDA). “The semi-automated IV bag…

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By: Matt Danford
January 11, 2024
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FDA issues safety notice for syringes made in China

Editor's Note The US Food and Drug Administration (FDA) issued a safety notice on November 30 regarding quality concerns related to several Chinese manufacturers of syringes. The FDA is evaluating these devices for potential problems, including leaks, breakages, and the presence of particles in the syringes.  According to the safety…

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By: Brita Belli
December 5, 2023
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FDA issues Safety Communication on certain N95 respirators, surgical masks

Editor's Note The Food and Drug Administration (FDA), on April 12, issued a Safety Communication recommending that consumers, healthcare providers, and facilities not use certain surgical N95 respirators and to use caution with certain surgical masks and pediatric face masks, all manufactured by O&M Halyard. The FDA says it is…

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By: Judy Mathias
April 13, 2023
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FDA updates reports of squamous cell carcinoma in capsule around breast implants

Editor's Note The Food and Drug Administration (FDA), on March 8, issued an update on reports of squamous cell carcinoma in the scar tissue (capsule) that forms around breast implants—both saline and silicone as well as textured and smooth. Previously, on September 8, 2022, the FDA informed the public of…

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By: Judy Mathias
March 16, 2023
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