Reported Mar 23, 2022 · Terminated
20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
CellEra LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CellEra LLC · 1045 Reed Dr Ste C · Monroe, OH · 45050-1717
Is this the product you have?
- 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
- Lot codes and dates
Lot 206999 GTIN 108562760086630085627600866600856276008659
- Amount recalled
- 4400 ea
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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