Z-2085-2019 Class II Terminated
FDA device recall Z-2085-2019 was initiated by CellEra LLC on Sep 1, 2016 and is designated Class II. Reason for recall: Adhesive border was not sticky enough. The recall status is terminated (terminated Feb 9, 2021). Affected quantity: 2110 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 31, 2019
- Initiation Date
- Sep 1, 2016
- Termination Date
- Feb 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2110 units
Product Description
VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
Reason for Recall
Adhesive border was not sticky enough.
Distribution Pattern
OH, PA, VA
Code Information
Lot # 161616 Cat. No. 20144 HIBCC bar code was M6692014409
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2085-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026