FDA Medical Device Recalls (openFDA)
CellEra LLC: VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
- Recall number
- Z-2085-2019
- Recalling firm
- CellEra LLC
- Product
- VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
- Status
- Terminated
- Initiated
- 2016-09-01
- Posted
- not on file
- Terminated
- 2021-02-09
- Reason
- Adhesive border was not sticky enough.
- Root cause
- Other
- Action
- firm contacted the facilities (via phone) that were shipped the merchandise and offered to take the product back.
- Quantity
- 2110 units
- Distribution
- OH, PA, VA
- Lot, serial or model codes
- Lot # 161616 Cat. No. 20144 HIBCC bar code was M6692014409
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAE
- Firm FEI
- 3007594734
- Firm city
- Monroe
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28