Vaccines, Blood & Biologics

CBER FY 2013 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.

CBER FY 2010 Recall Postings
  Allergenic  Blood  Blood Deriv.  Device IVD Source Plasma Therapeutic Tissue Vaccine Total Events
by Class
Class I                4    4
Class II 1  859 1  20  1  191    29  1  1103
Class III 4  240 4  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    105 4 1679

Direct Recall Classification (DRC) Related Data 2013:

Direct Recall Classification (DRC) Related Data 2013
Number of AI Requests during FY13  787
Number of Alerts to Possible Recall sent during FY 13 17
Number of DRC Recalls Classifed during FY 13 703

 

Page Last Updated: 03/19/2015
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