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Understanding Product Recalls and FDA Warnings, Lawyers for Drugs and Devices

Written by Class Action Lawyer on . Posted in Product Recall News

The FDA is the  decision making  body in the United States for all product recalls and warnings. Dangerous drugs and medical and surgical devices are approved and recalled by the FDA.

Product Recall Classifications:

    CLASS I – Involves a health hazard situation where there is reasonable probability that the use of the product will cause serious, adverse health consequences or death.

    CLASS II – Involves a potential health hazard situation where there is a remote probability of adverse health consequences from the use of the product.

    CLASS III – Involves a situation where the use of the product is not likely to cause adverse health consequences.

Class I, Class II, and Class III. Class I recalls involve products deemed to be dangerous enough to cause serious adverse health consequences or death. Class II recalls are used for products that might cause a temporary or medically reversible health problem.

With Class III recalls, consumers are not likely to experience an adverse health reaction when exposed to the recalled products. So why does the FDA recall them?

In most cases, it’s because they violate FDA labeling or manufacturing regulations. They may be products shipped in defective containers, products imported without a label in English, or products with incorrect content descriptions.

Examples of Class I Recalls

CooperVision AVAIRA Toric and Sphere Soft Contact Lenses

Recall Class: Class I

Date Recall Initiated: August 19, 2011; expanded on November 15, 2011

Product(s): AVAIRA (enfilcon A) TORIC and SPHERE soft (Hydrophilic) Contact Lenses

The Avaira Sphere Contact Lenses recall is an expansion of the Class I recall of CooperVision’s Avaira Toric Contact Lenses.

Stryker Leibinger USA., Stryker Custom Cranial Implant Kits

Class 1 Recall

Class II Recalls

FDA Recalls DePuy ASR Hip Implants

On July 17, 2010, the U.S. Food and Drug Administration issued a nationwide recall for the DePuy ASR Hip System.  This was a Class 2 Recall which are issued on products that have a lesser chance of causing major injuries or death, but  there is still the possibility of serious enough adverse effects to have irreversible consequences.

If you were injured by an FDA recalled dangerous drug or medical implant contact class action lawyer Network

 

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