CellEra LLC recalls 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
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…
Read the official notice →- Date
- 2022-03-23
- Country
- United States
- Brand
- CellEra LLC
- Product
- 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
- Classification
- Class III
- Units
- US Nationwide distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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