FDA Medical Device Recalls (openFDA)
CellEra LLC: 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
- Recall number
- Z-0805-2022
- Recalling firm
- CellEra LLC
- Product
- 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
- Status
- Terminated
- Initiated
- 2021-12-15
- Posted
- 2022-03-16
- Terminated
- 2023-10-16
- Reason
- Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
- Root cause
- Labeling Change Control
- Action
- On December 15, 2021, the firm notified customers who had received product from CellEra within the past six months. The firm requested these customers hold any merchandise on hand pending receipt of replacement IFU's. The firm communicated with those companies to determine how many new IFU's they require for their inventory and for their customers.
- Quantity
- 11770 ea
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot 212299, 200999 GTIN 10850005565250, 00850005565253, 00850005565246
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FRO
- 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