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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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CBER FY 2011 Recall Postings

Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

 Allergenic Blood Blood Deriv. DeviceIVDSource PlasmaTherapeuticTissueVaccineTotal Events
by Class
Class I        2  2
Class II2 8742 11  109  7  1,005
Class III1 2311 2 2 132  4  373
Mixed Class (Cl.
I/II)
       1 1
Mixed Class (Cl.
I/III)
          
Mixed Class (Cl.
II/III)
  125     2  127
 Total Events
by Product
 3 1,230 3 13 2 241  16  1,508

Direct Recall Classification (DRC) Related Data 2011:

Number of AI Requests during FY11 804
Number of Alerts to Possible Recall sent during FY 11156
Number of DRC Recalls Classifed during FY 11787