FDA: Recalled Medical Devices for 2011

Dec 6th, 2011 | By | Category: FDA News

The FDA announced its Recalled Medical Devices for 2011 December 6th, Tuesday. The Recall Classifications are divided into three classes according to the potential level of hazard.

Class I: Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.

Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.

Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.

See more here. 


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