America’s Unsafe Drugs and Medical Products

Source: Christopher Furlong / Getty Images

Faulty Software in Ventilator
> Issue date: July 12, 2019
> Type of alert: Recall

The Hamilton-G5 ventilator sporadically displays an error message that communication between the device and its control panel has been lost and then sounds an alarm before turning itself off. The manufacturer has a new software version that reduces the probability of such an event. The company has received 14 complaints about the error messages and had shipped 4,338 of the devices between November 2007 and October 2018. 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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Possible Lack of Sterility in Ophthalmic Products
> Issue date: July 10, 2019
> Type of alert: Recall

Altaire Pharmaceuticals is voluntarily recalling several ophthalmic products sold over-the-counter at CVS pharmacies due to an FDA determination that the products may not be sterile. According to the FDA, “Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.” The list of recalled products is available at the FDA website.

Altaire Pharmaceuticals is voluntarily recalling several ophthalmic products that may not be sterile sold over-the-counter at Walgreens pharmacies. According to the FDA, “Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.” The list of recalled products is available at the FDA website.

Altaire Pharmaceuticals is voluntarily recalling several ophthalmic products sold to Perrigo that may not be sterile, which distributes them to its own customers. According to the FDA, “Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.” The list of recalled products is available at the FDA website.

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Chemotherapy Drug May Contain Glass Particulate
> Issue date: July 2, 2019
> Type of alert: Recall

Fresenius Kabi USA is voluntarily recalling two lots of its Fluorouracil intravenous chemotherapy drug used to treat a variety of cancers due to the potential for glass particulate. Using a product with glass particulate could be life-threatening.

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Infusion Pump Syringe May Leak
> Issue date: July 1, 2019
> Type of alert: Recall

Becton Dickinson is recalling 2,900 SmartSite Syringe Administration sets that are used with an infusion pump to deliver fluids to patients. The sets may leak causing under‐infusion of critical medications, delay or interruption of infusions, contamination of the fluid paths and/or health care provider exposures to hazardous medications. 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.”

Source: Christopher Furlong / Getty Images

Device Used in Bypass Surgery May Rupture
> Issue date: July 1, 2019
> Type of alert: Recall

Edwards LifeSciences is recalling 727 IntraClude Intra-Aortic Occlusion devices due to the risk that the balloon used to block and vent the aorta during surgery may rupture causing serious adverse health consequences. 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.”