FDA Device recall Z-0804-2022
20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
- FDA Device
- Class III
- terminated
- Published 2022-03-23
On 2022-03-23 the FDA classified a Class III recall of 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box by Cellera, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0804-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-12-15 |
| Published | 2022-03-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cellera |
| Distribution | US |
Product
20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
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.
Identifiers
| code_info | Lot 212299 GTIN 10856276008700, 00865276008703, 00856276008697 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0804-2022%22
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