FDA Device recall Z-0801-2022
20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
- FDA Device
- Class III
- terminated
- Published 2022-03-23
On 2022-03-23 the FDA classified a Class III recall of 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/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-0801-2022 |
| 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
20500 Vitale Silver calcium Alginate Dressing Ropes, 5/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 200999 GTIN 10856276008649, 00856276008642, 00856276008635 |
|---|
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-0801-2022%22
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