20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 206999 GTIN 10856276008663, 00856276008666, 00856276008659
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- CellEra LLC
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
Product Codes/Lot Numbers:
Lot 206999 GTIN 10856276008663, 00856276008666, 00856276008659
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0803-2022
Related Recalls
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.
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.
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.