20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
FDA Device Recall #Z-0802-2022 — Class III — December 15, 2021
Recall Summary
| Recall Number | Z-0802-2022 |
| Classification | Class III — Low risk |
| Date Initiated | December 15, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CellEra LLC |
| Location | Monroe, OH |
| Product Type | Devices |
| Quantity | 9200 ea |
Product Description
20522 Vitale Silver calcium Alginate Dressings 2x2, 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 Pattern
US Nationwide distribution.
Lot / Code Information
Lot 229999 GTIN 10856276008762, 00856276008765, 00856276008758
Other Recalls from CellEra LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0804-2022 | Class III | 20545 Vitale Silver calcium Alginate Dressings ... | Dec 15, 2021 |
| Z-0803-2022 | Class III | 20544 Vitale Silver calcium Alginate Dressings ... | Dec 15, 2021 |
| Z-0801-2022 | Class III | 20500 Vitale Silver calcium Alginate Dressing R... | Dec 15, 2021 |
| Z-0805-2022 | Class III | 20548 Vitale Silver calcium Alginate Dressings ... | Dec 15, 2021 |
| Z-2085-2019 | Class II | VITALE Silicon Foam Dressings 4"x4" Cat. No. 2... | Sep 1, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.