Device product
VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
Z-2085-2019
Product summary
- Firm
- CellEra LLC
- Event
- Event 83281
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2110 units
- Official record key
device-enforcement:Z-2085-2019
Official wording
Reason: Adhesive border was not sticky enough.
Code information: Lot # 161616 Cat. No. 20144 HIBCC bar code was M6692014409
Distribution pattern: OH, PA, VA
Derived failure modes
-
Unknown
Adhesive border was not sticky enough.