FDAFDA · Food and drugs·Recall number Z-0804-2022
20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
Published March 23, 2022 · Recall initiated: December 15, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated
Recall details
- Manufacturer
- CellEra LLC
- Distributor
- US Nationwide distribution.
- Lot
- Lot 212299 GTIN 10856276008700, 00865276008703, 00856276008697
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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