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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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CBER FY 2013 Recall Posting

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        4  4
Class II1 8591 20 1 191  29 1 1103
Class III4 2404 13 5 88  69 3 426
Mixed Class (Cl.
I/II)
          
Mixed Class (Cl.
I/III)
          
Mixed Class (Cl.
II/III)
  141    3  146
 Total Events
by Product
 5 1240 5 33 8 279  10541679

 

Direct Recall Classification (DRC) Related Data 2013:

 

Number of AI Requests during FY13 787
Number of Alerts to Possible Recall sent during FY 1317
Number of DRC Recalls Classifed during FY 13703