Recall Z-2085-2019— CellEra LLC

Name: FDA recall Z-2085-2019
Creator: U.S. Food and Drug Administration
Published: 2016-09-01

Class II · Terminated

Class II FDA medical device recall by CellEra LLC, initiated 2016-09-01, terminated 2021-02-09. FDA's recall record names no specific 510(k) clearance for this event. Product: VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144. Reason: Adhesive border was not sticky enough..

Recalling firm: CellEra LLC
Classification: Class II
Status: Terminated
Initiated: 2016-09-01
Terminated: 2021-02-09
Firm location: Monroe, OH, United States

Product description

VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144

Reason for recall

Adhesive border was not sticky enough.

Data sourced from openFDA. This site is unofficial and independent of the FDA.