Posts Tagged 'Recall'

What Exactly is a Hernia Mesh and Why Have Some Been Recalled?

what is a hernia mesh - hernia mesh recallLike so many other medical terms, hernia is a word that gets used frequently without the specifics of the term’s definition being widely known. This, in turn, makes it difficult to understand and explain one of the methods used to repair a hernia; the hernia mesh surgical implant, and some of the problems that have been associated with it.

To best understand the hernia mesh, we first need to ...

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Valsartan Recall Extends to Sixth Drug

teva latest to recall valsartan drugs over contamination concernsThe recall of valsartan batches contaminated with a chemical classified as a probable human carcinogen has extended to a sixth drug. As a result, Teva Pharmaceuticals has recalled a variety of valsartan-based medications manufactured by Mylan India.

The recall includes amlodipine-valsartan and amlodipine-valsartan-hydrochlorothiazide combination tablets. Like the other valsartan medications pulled off of shelves in recent recalls, the contamination appears to come from a compound known ...

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Valsartan Contamination and Cancer: What are the Risks?

valsartan recalled over contamination cancer concernsRecent news stories regarding certain heart medications also came with a startling warning: patients taking medications using the ingredient valsartan may have been unknowingly ingesting chemicals that could be carcinogenic. The issue stems from contamination of valsartan batches with chemicals that are generally used in a wide variety of industrial applications from making rocket fuel to processing fish.

The chemical at the center of the story, NDMA or N-nitrosodimethylamine, was discovered ...

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Zimmer Biomet Recalls Shoulder Device Due to High Fracture Rates

zimmer recalls shoulder implantMedical device manufacturer Zimmer Biomet has recalled its Comprehensive Reverse Shoulder implant. The device was intended for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and had a previously failed shoulder joint replacement.

The Comprehensive Reverse Shoulder is being recalled because the devices are fracturing at a higher rate than is stated in the product’s labeling. Device fractures may result in the need for revision surgeries ...

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Medtronic Heart Pump Recalled Over Potentially Fatal Flaw

medtronic heartware hvad system under recallLast year, medical devices manufacturer Medtronic bought HeartWare, the company behind a heart pump known as the HVAD system. The deal cost Medtronic $1 billion.

Prior to the purchase, HeartWare had received not one, but two safety letters from the U.S. Food and Drug Administration over issues related to the HVAD pump. These letters detailed agency concerns over the effects of moisture on the HVAD system. Medtronic was aware of ...

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Hospira Recalls Defective Infusion Pumps

hospira to recall infusion pumpsThe pharmaceutical company and medical device manufacturer Hospira, Inc., has issued a Class I recall of its Plum A+ and A+3 infusion pumps, according to the FDA website. The pumps have an alarm that is supposed to trigger when therapy is interrupted. However, some of the pumps’ alarms fail to sound in situations that should trigger them.

Class I recalls are the most serious class of recalls, and are issued when recalled ...

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