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.

 

	Allergenic	Blood	Blood Deriv.	Device	IVD	Source Plasma	Therapeutic	Tissue	Vaccine	Total Events by Class
Class I								1		1
Class II	2	879	3	19	2	156		41	1	1,103
Class III	3	275	4	13	8	245		12	7	567
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	5	1,275	7	33	10	401		55	8	1,794

 

Direct Recall Classification (DRC) Related Data 2012:

 

Number of AI Requests during FY12	857
Number of Alerts to Possible Recall sent during FY 12	67
Number of DRC Recalls Classifed during FY 12	802