Z-2085-2019Class II

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

Name: Z-2085-2019 VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
Creator: CellEra LLC
Published: 2016-09-01
License: https://open.fda.gov/license/

CellEra, LLC / initiated 2016-09-01 / Terminated

FDA source

CellEra LLC began a recall of VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144 on 2016-09-01. FDA classified it as Class II and gives the reason as "Adhesive border was not sticky enough". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2085-2019
Classification: Class II
Status: Terminated
Initiated: 2016-09-01
Posted: 2019-07-25
Terminated: 2021-02-09
Recalling firm: CellEra, LLC
Product: VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
Product code: NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Reason for recall: Adhesive border was not sticky enough.
FDA root cause: Other
Action: firm contacted the facilities (via phone) that were shipped the merchandise and offered to take the product back.
Quantity in commerce: 2110 units
Distribution: OH, PA, VA
Product codes and lots: Lot # 161616 Cat. No. 20144 HIBCC bar code was M6692014409

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2085-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2085-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-25

Product code NAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)