ComplianceOnline

FDA Classifies Recall of Alaris PC Units Model 8015 as Class I Recall

  • Date: December 01, 2010
  • Source: Admin
Webinar All Access Pass Subscription Abstract:

The FDA has classified CareFusion’s decision to recall approximately 17,000 Alaris® PC units (model 8015) which had been manufactured or serviced between December 2008 and September 2009 as Class I recall. CareFusion (denoted as CFN in the NYSE) is a leading global medical device company. The FDA classifies the recall of those items as Class I recall when there is substantial possibility that the use or exposure to the product will call serious health hazards or even death.

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