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CellEra LLC recalls 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
Recalled March 23, 2022 · FDA recall Z-0805-2022 · CellEra
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. · FDA Class III
Units
11770 ea
Sold at
US Nationwide distribution.
Description
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.
Product
20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
Manufacturer(s)
CellEra LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →