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