FDADecember 15, 2021device
20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
cellera
UPCs
1085627600866300856276008666
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDA20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box2021-12-15
- FDA20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box2021-12-15
- FDA20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box2021-12-15
- FDA20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box2021-12-15
- FDAVITALE Silicon Foam Dressings 4"x4" Cat. No. 201442016-09-01
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