Recall Z-2085-2019 ยท NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
CellEra LLC
VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
| Date | Sep 1, 2016 |
| Status | Terminated |
| Reason | Adhesive border was not sticky enough. |
| Root cause | Other |
| Action | firm contacted the facilities (via phone) that were shipped the merchandise and offered to take the product back. |
| Quantity | 2110 units |
| Distribution | OH, PA, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.