Vaccines, Blood & Biologics

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.

 AllergenicBloodBlood Deriv.DeviceIVDSource PlasmaTherapeuticTissueVaccineTotal Events
by Class
Class I       1 1
Class II28793192156 4111,103
Class III32754138245 127567
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
51,27573310401 5581,794

Direct Recall Classification (DRC) Related Data 2012:

Number of AI Requests during FY12857
Number of Alerts to Possible Recall sent during FY 1267
Number of DRC Recalls Classifed during FY 12802

 

Page Last Updated: 08/21/2014
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