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  1. Safety & Availability (Biologics)

CBER FY 2017 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 2017 Recall Postings
  Allergenic Blood Blood Deriv. Device IVD Source Plasma Therapeutic Tissue Vaccine Total Events
by Class
Class I                   0
Class II 1 378   7   22   19   427
Class III 2 124 6 4 3 44   1 1 185
Mixed Class (Cl.
I/II)
                   
Mixed Class (Cl.
I/III)
                   
Mixed Class (Cl.
II/III)
  56       1       57
Total Events
by Product
3 558 6 11 3 67   20 1 669
Direct Recall Classification (DRC) Related Data 2017
Number of AI Requests during FY 17 628
Number of Alerts to Possible Recall sent during FY 17 1
Number of DRC Recalls Classifed during FY 17 655

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