Healthcare Business

America's Unsafe Medical Products

Paul Ausick

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.

Torrent Pharmaceuticals Losartan Tablets
> Issue date: January 22, 2019
> Type of alert: Recall

Torrent is expanding a voluntary recall of two types of losartan tablets used to treat hypertension. Six lots of losartan potassium and hydrochlorothiazide tablets were found to have trace amounts of an unexpected carcinogen in tablets manufactured by Hetero Labs. The company has received no reports of adverse events related to this recall.

Treating Peripheral Arterial Disease
> Issue date: January 17, 2019
> Type of alert: Letter to health care providers

The FDA notified peripheral interventionists and vascular medicine physicians that a recent meta-analysis of randomized trials of paclitaxel-coated balloons and paclitaxel-eluting stents to treat peripheral arterial disease suggests a “possible increased mortality rate after two years” compared to patients treated with non-coated balloons or bare-metal stents.

Medtronic Cranial Surgery Navigation System
> Issue date: January 8, 2019
> Type of alert: Recall

Medtronic’s Synergy cranial system and StealthStation S7 cranial software are being recalled following reports that incorrect information is being displayed during biopsy procedures. If the defect should occur, “the neurosurgeon could potentially insert the surgical tool too deeply and damage the patient’s healthy tissue, brain or blood vessels.” The recall was initiated in September 2018 and has been designated a Class I recall, the FDA’s most serious category. Using these devices may cause injuries or death.