Vaccines, Blood & Biologics

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. Device IVD Source Plasma Therapeutic Tissue Vaccine Total Events
by Class
Class I               2   2
Class II 2 874 2 11   109   7   1,005
Class III 1 231 1 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 11 156
Number of DRC Recalls Classifed during FY 11 787

 

Page Last Updated: 08/20/2014
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