America’s Unsafe Medical Products

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The U.S. Food and Drug Administration (FDA) has issued 17 new safety alerts since the end of May, 14 related to product recalls including one for an infant formula power sold at Walmart. The agency also warned of possible cyberattacks on a Medtronic insulin pump.

The FDA issues safety alerts to provide timely new safety information on human drugs, medical devices, vaccines and other products including biologics, dietary supplements and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.”

The following list includes all MedWatch alerts for 2019 through June 27. There are several types of alerts, including letters to health care providers, warnings to users, drug safety notices and recalls. The 2019 alerts are listed in reverse chronological order with the most recent listed first. Included are the type of alert and the issue date.

Fluid Warming System
> Issue date: June 27, 2019
> Type of alert: Recall

Vyaire enFlow Fluid Warming System cartridges used to warm blood and other intravenous fluids before administering the fluids to patients may contaminate its disposable cartridges due to elution of aluminum in the cartridge. The FDA is recalling nearly 2.9 million of the cartridges in this Class I recall, indicating that continued use of these devices may cause serious injury or death.

Cybersecurity Risk to Insulin Pumps
> Issue date: June 27, 2019
> Type of alert: Safety Warning

The FEA is warning patients and health care providers that certain Medtronic MiniMed insulin pumps are vulnerable to cyberattack through the device’s wireless capability. For more details, consult the FDA document.

Impurity Found in Losartan Tablets
> Issue date: June 26, 2019
> Type of alert: Recall

Macleods Pharmaceuticals is voluntarily recalling 32 lots of Losartan 50 mg and Losartan Potassium/Hydrochlorothiazide 12/5 mg, 50 mg and 100 mg tablets after finding trace amounts of an impurity in the tablets manufactured by Hero Labs.

Endotracheal Tube Connection May Fail
> Issue date: June 25, 2019
> Type of alert: Recall

Teleflex has voluntarily recalled several lots of its oral and nasal intubation devices following complaints that the connector is disconnecting from the endotracheal tube. There are four reported deaths from this failure and additional reports of serious injury where the disconnection may have been a factor. This is a Class I recall

Potential Metal Foreign Matter in Infant Formula Powder
> Issue date: June 21, 2019
> Type of alert: Recall

Perrigo has issued a voluntary recall of its Parent’s Choice Advantage Infant Formula Milk-Based Powder With Iron due to the potential presence of metal foreign matter in one lot of the product. The formula is sold only at Walmart stores, and 23,388 containers are being recalled. See the FDA announcement for more details.

Endotracheal Tube Connection May Fail
> Issue date: June 21, 2019
> Type of alert: Recall

This is an earlier version of the June 25 recall notice. Teleflex Medical is recalling nearly 6.1 million of the devices.

Lack of Assurance That Sterile Products Are in Fact Sterile
> Issue date: June 20, 2019
> Type of alert: Recall

Infusion Options is recalling all lots of its sterile products due to a lack of assurance of their sterility.