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Tag: medical device recalls

May
14

Pointing Fingers: Who’s Liable When a Defective Product Causes Harm

PA swift and thorough product recall is the best way to mitigate any legal liability risk from a defective product, removing inventory from the market before problems become pervasive. But in many cases, product defects or dangers aren’t discovered until after harm has occurred and liability cannot be avoided. Product liability laws enable consumers to sue those parties responsible when a product causes property damage, injury or death.

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Apr
23

Birth of a recall

When a consumer’s smartphone spontaneously combusts, the word-of-mouth news spreads to millions within days if not hours. If a certain blood pressure medicine is contaminated with a potentially cancer-causing agent, it could take months before routine testing uncovers the defect, and weeks more before the news and notifications slowly trickle.

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Dec
18

Be prepared: Lithium-ion batteries pose severe recall challenges for medical devices

The reduced size, weight and power consumption of lithium-ion (Li-ion) batteries has been a boon for medical device manufacturers seeking to create more portable and convenient products. But the efficiency gains of Li-ion batteries are tempered by the increased safety risks and regulatory concerns the technology poses. As multitudes of viral videos confirm, products with Li-ion rechargeable batteries have the potential to overheat, explode and catch fire.

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Aug
29

The FYI on UDI

It has been five years since the Food and Drug Administration (FDA) released a final rule establishing a unique device identification (UDI) system for the medical device industry. The benefits are numerous and include more accurate reporting of adverse events, a reduction in medical errors, and more effective management of medical device recalls.

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Nov
02

Budgeting for a Pharmaceutical or Medical Device Recall

It’s budgeting season, and most leaders are hoping and planning for a banner year. New product developments. Innovative strategies. Expanded market share. Everyone hopes they will avoid any sort of crisis in the coming year, and as a result, few plan for one. But one of the most disruptive crises medical device and pharmaceutical companies will face is also among the most likely – product recalls. Consider this: Through Q3 2017, 144 companies experienced more than one pharmaceutical or medical device recall.

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