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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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CBER FY 2012 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        1  1
Class II2 8793 19 2 156  41 1 1,103
Class III3 2754 13 8 245  12 7 567
Mixed Class (Cl.
I/II)
       1 1
Mixed Class (Cl.
I/III)
          
Mixed Class (Cl.
II/III)
  121  1   1  123
 Total Events
by Product
 5 1,275 7 33 10 401  5581,794

 

Direct Recall Classification (DRC) Related Data 2012:

 

Number of AI Requests during FY12 857
Number of Alerts to Possible Recall sent during FY 1267
Number of DRC Recalls Classifed during FY 12802