20544 Vitale Silver calcium Alginate Dressings 4x4 recall
20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
Why was 20544 Vitale Silver calcium Alginate Dressings 4x4 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 206999 GTIN 10856276008663, 00856276008666, 00856276008659
- Product
- 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
- Recalling firm
- CellEra LLC
- Quantity
- 4400 ea
- Distribution
- US Nationwide distribution.
- Recall date
- March 23, 2022
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)