20500 Vitale Silver calcium Alginate Dressing Ropes — Class III medical device recall Z-0801-2022
Terminated recall by CellEra LLC, reported 2022-03-23, distributed nationwide. Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cle
| Recall number | Z-0801-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CellEra LLC, Monroe, OH, United States |
| Recall initiated | 2021-12-15 |
| Classified | 2022-03-16 |
| Reported by FDA | 2022-03-23 |
| Terminated | 2023-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 30,000 units |
| UPC / GTIN / UDI-DI | 00856276008635, 00856276008642, 10856276008649 |
| Lot numbers | 200999 |
Product
20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0801-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.