CBER FY 2010 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		1.079		7	1	254		13	6	1354
Class III		215		3	3	77		2		306
Mixed Class (I/II)*
Mixed Class (I/III)*
Mixed Class (II/III)*		220								220
Total Events by Product*	0	1,514	0	10	4	331	0	16	6	1,881

^* Mixed Class Recall - A recall event containing a combination Class I, II and/or Class III.
^* Recall Event - Recall actions performed by industry are assigned Event numbers by the agency's Recall Enterprise System (RES).

Direct Recall Classification (DRC) Related Data:

Number of DRC Additional Information Requests during FY10	989
Number of Recall Alerts sent during FY 10	253
Number of DRC Recalls Classifed during FY 10	1,191