America’s Unsafe Medical Products

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Stryker LIFEPACK 15 Monitors/Defibrillators
> Issue date: February 1, 2019
> Type of alert: Recall

Stryker is voluntarily recalling the monitor/defibrillators to update the system’s firmware. The company has received 58 complaints of a device lock-up (blank monitor while power indicators are lighted; no response from the keypad; and no device functions). There are 13,003 devices affected by this recall.

Roche Diagnostics CoaguChek XS PT Test Strips
> Issue date: February 1, 2019
> Type of alert: Recall

The strips manufactured by Roche were sold by Terrific Care or Medex Supply to test patient response to warfarin blood thinner. The distributors are recalling 759 boxes because the test strips are delivering inaccurate results compared to laboratory results.

West Pharmaceutical Services Fluid Transfer Systems
> Issue date: February 1, 2019
> Type of alert: Recall

The company is recalling 38.8 million Vial2Bag fluid transfer systems because the devices may not adequately transfer concentrated medication from a vial to an IV bag before infusion into a patient’s vein. The FDA received 16 complaints of serious problems when the 13mm device was used with oxytocin for pregnant women during labor and delivery.

Infants’ Ibuprofen
> Issue date: January 30, 2019
> Type of alert: Recall

Tris Pharma issued a voluntary recall of three lots of infants’ ibuprofen in early December of last year. The dosage may exceed the label-specified description. The drug was sold at Family Dollar (Family Wellness brand), CVS (CVS Health brand) and Walmart (Equate brand). Tris Pharma has received no reports of adverse effects.


Nature’s Rx Silver Bullet 10x Male Enhancement Drug
> Issue date:

January 29, 2019
> Type of alert: Recall

The company is conducting a voluntary recall of its Silver Bullet 10x male enhancement drug because the product contained undeclared amounts of sildenafil and tadalafil, the active ingredients in Viagra and Cialis, respectively.  The ingredients pose a serious health risk to users taking other drugs that, for example, may lower a person’s blood pressure to dangerous levels.

Draeger Medical Breathing and Anesthesia Sets
> Issue date: January 25, 2019
> Type of alert: Recall

The company is recalling 1,200 VentStar and ID breathing circuits and anesthesia sets sold in the United States to provide mechanical ventilation and critical breathing support to patients. The devices may have been incorrectly assembled, resulting in a short-circuit in the breathing hose. That may lead to irreversible patient harm, up to and including death. This is a Class I recall.