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» Medical device units recalled in Q2 represent eight-quarter high | MedCity News.

Medical device units recalled in Q2 represent eight-quarter high

August 23, 2012 10:43 am by Arundhati Parmar

An analysis of data from the U.S. Food and Drug Administration conducted by ExpertRECALL shows that 123.5 million medical device units were recalled in the second quarter of the year, representing an eight-quarter high.

The last time recalls affected 100 million units was the third quarter of 2010.

The number of actual recalls in the second quarter – 242 – fell 13 percent compared with the number of recalls in the previous quarter, but was up 4 percent compared with the second quarter of 2011.Three of second-quarter recalls affected more than 10 million units.

Class I recalls, considered to be the most serious because affected units have the potential to cause severe injury and death, were less than 1 percent of affected units.

The medical device recalls affected both domestic and international markets with 70 of the 242 affecting only U.S. customers while only one recall affected international consumers alone.

Pharma fared better with only 69 drug recalls during the second quarter, essentially flat compared to the first quarter recalls. But, the actual number of units recalled fell dramatically in the second quarter to just one-tenth of the affected units in the first quarter. The reduction represents a 58 percent decrease in the number of affected units, compared with the second quarter of 2011.

Six recalls were hit with a Class I classification by the FDA, while 45 were designated Class II.

A summary of the findings can be seen here.