America’s Unsafe Drugs and Medical Products

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Mislabeled Hemophilia Treatment Recalled
> Issue date: July 19, 2019
> Type of alert: Recall

Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials that may contain instead Bayer’s Jivi FVIII hemophilia A treatment. Patients in possession of vials from the affected lot numbers should immediately stop using the product and contact their physician.

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Infusion Pump Tube Collapses
> Issue date: July 18, 2019
> Type of alert: Recall

Becton Dickinson has recalled Alaris infusion sets used to deliver fluids including blood and medications to patients. The devices could potentially deliver the fluid faster than expected or even deliver unintended doses. The company is recalling more than 151 million of the devices distributed in the United States between July 1, 2016, and April 18, 2019.

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Neonatal/Infant Ventilation Device May Leak
> Issue date: July 17, 2019
> Type of alert: Recall

The Neonatal ConchaSmart Breathing Circuit is a mechanical ventilating device that hospitals use to deliver breathing assistance or general medical gases newborns and infants. Teleflex is recalling the devices due to reports of cracks that may cause the gas to leak and not reach the patient, which could lead to adverse consequences, including death. Teleflex delivered 300 of the recalled devices to U.S. health care facilities between December 2018 and January 2019. This is a 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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Magnetic Interference Between Certain Implanted Devices
> Issue date: July 16, 2019
> Type of alert: Letter to health care providers

The FDA is notifying health care providers that possible magnetic interactions between cerebrospinal fluid (CSF) shunt systems and some hearing implants that contain magnets may lead to unintended changes in the programmable CSF shunt valve settings causing overdrainage or underdrainage of CSF. Patients could experience a variety of symptoms, including headaches, and if the symptoms are not treated can progress to loss of consciousness or even death.

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Hospital Infant Warmers May Break
> Issue date: July 12, 2019
> Type of alert: Recall

GE Healthcare is recalling its Giraffe Warmers and Panda iRes Warmers used by hospitals and clinicians to care for infants. The company has notified its hospital customers and will replace all cracked or damaged panels and latches on the warmers at no cost. This alert is an update of one issued in June and lists model numbers for the devices. GE has received 338 complaints related to this problem and had shipped more than 25,000 of the devices between October 2007 and February 2019. This is a Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.”