FDA recall Z-2085-2019
CellEra LLC · Class II · device
Product
VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
Reason for recall
Adhesive border was not sticky enough.
Distribution
OH, PA, VA
Key facts
- Status
- Terminated
- Initiation date
- 2016-09-01
- Report date
- 2019-07-31
- Termination date
- 2021-02-09
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Monroe, OH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2085-2019