CellEra LLC

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0805-2022Class III20548 Vitale Silver calcium Alginate Dressings 4x8, 5/boxDecember 15, 2021
Z-0801-2022Class III20500 Vitale Silver calcium Alginate Dressing Ropes, 5/boxDecember 15, 2021
Z-0804-2022Class III20545 Vitale Silver calcium Alginate Dressings 4x5, 10/boxDecember 15, 2021
Z-0803-2022Class III20544 Vitale Silver calcium Alginate Dressings 4x4, 10/boxDecember 15, 2021
Z-0802-2022Class III20522 Vitale Silver calcium Alginate Dressings 2x2, 10/boxDecember 15, 2021
Z-2085-2019Class IIVITALE Silicon Foam Dressings 4"x4" Cat. No. 20144September 1, 2016