America’s Unsafe Drugs and Medical Products

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Compounded Drugs May Not Be Sterile
> Issue date: October 10, 2019
> Type of alert: Recall

Innoveix Pharmaceuticals is voluntarily recalling all its sterile compounded drug products due to a lack of assurance of sterility. The affected products are injectable human chorionic gonadotropin (HCG) and injectable sermorelin w/GHRP2.

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Infusion Sets May Leak Fluid Out of Air Vents
> Issue date: October 8, 2019
> Type of alert: Recall

ICU Medical is voluntarily recalling certain lots of its Plum and Sapphire Microbore Infusion sets due the potential for small amounts of fluid to leak out of the inline filter air vents.

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Catheter Used in Vascular Systems at Risk of Separating and Detaching Fragments
> Issue date: October 8, 2019
> Type of alert: Recall

Medtronic is recalling 106,298 6 French Sherpa NX Active Guide Catheters in which the outer material may separate from the device that could result in detached fragments exposing the underlying stainless-steel braid. This is an FDA Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.”

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Update on Lung Injury Due to Vaping
> Issue date: October 4, 2019
> Type of alert: Safety communication

As of the issue date, the FDA had received more than 1,000 reports of lung injuries, including some that resulted in deaths, following the use of vaping devices. As of October 29, the Centers for Disease Control and Prevention (CDC) reported 1,888 cases of e-cigarette, or vaping, product use associated lung injury (EVALI); 37 deaths have been confirmed in 24 states. Most patients report using THC-containing products (THC is the psychoactive ingredient in marijuana) and many states have temporarily stopped the sales of these products.

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Cybersecurity Vulnerabilities Tied to Using Certain Medical Devices
> Issue date: October 1, 2019
> Type of alert: Safety communication

Security researchers have identified 11 cybersecurity vulnerabilities called Urgent/11 that could allow anyone to take control of certain medical devices from a remote location. Once control is established, the device’s function may be changed, a denial of service could occur or information or logical flaws could be introduced to prevent the device from functioning.