CBER FY 2018 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 | 305 | 5 | 21 | 15 | 346 | |||||
| Class III | 2 | 106 | 9 | 2 | 80 | 2 | 1 | 202 | ||
| Mixed Class (Cl. I/II) |
||||||||||
| Mixed Class (Cl. I/III) |
3 | |||||||||
| Mixed Class (Cl. II/III) |
59 | 1 | 3 | 60 | ||||||
| Total Events by Product |
2 | 470 | 14 | 2 | 102 | 22 | 1 | 613 |
| Number of AI Requests during FY 18 | 624 |
|---|---|
| Number of Alerts to Possible Recall sent during FY 18 | 0 |
| Number of DRC Recalls Classifed during FY 18 | 599 |