CellEra LLC recalls 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box

Recall date

December 15, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0804-2022

FDA classification

Class III

Brand / firm

CellEra LLC

Sold / distributed

US Nationwide distribution.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box