CBER FY 2019 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 | 2 | |||||||
| Class II | 289 | 3 | 5 | 30 | 13 | 340 | ||||
| Class III | 1 | 121 | 2 | 5 | 1 | 227 | 1 | 358 | ||
| Mixed Class (Cl. I/II) |
2 | 2 | ||||||||
| Mixed Class (Cl. I/III) |
0 | |||||||||
| Mixed Class (Cl. II/III) |
33 | 33 | ||||||||
| Total Events by Product |
1 | 443 | 5 | 11 | 1 | 257 | 16 | 1 | 735 |
| Number of AI Requests during FY 19 | 754 |
|---|---|
| Number of Alerts to Possible Recall sent during FY 19 | 0 |
| Number of DRC Recalls Classified during FY19 | 720 |