FDA-Device2022-03-23Class III
20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
CellEra LLC
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
4400 ea
Manufactured in
1045 Reed Dr Ste C, N/A, Monroe, OH, United States
Products
20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0803-2022Don't want to check this manually?
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