# FDA recall Z-0804-2022

> **CellEra LLC** · Class III · device recall initiated 2021-12-15.

## Product

20545 Vitale Silver calcium Alginate Dressings 4x5, 10/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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0804-2022
- **Recalling firm:** CellEra LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-15
- **Report date:** 2022-03-23
- **Termination date:** 2023-10-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Monroe, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0804-2022

## Citation

> AI Analytics. FDA recall Z-0804-2022. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0804-2022. Source: US FDA. Licensed CC0.

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