Calcium Alginate Wound Dressings Recalled for Incorrect Instructions
CellEra LLC is recalling Vitale Silver calcium alginate wound dressings nationwide due to incorrect instructions for use containing language beyond FDA-cleared content.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recalls involving labeling and documentation issues are typically scored 1–2. This recall involves incorrect Instructions for Use with language beyond FDA-cleared content. No illnesses or injuries are reported in the source material.
Plain-English summary
CellEra LLC is recalling the Vitale Silver calcium alginate wound dressings (2x2 inch, 10 per box, Lot 229999) distributed nationwide. The recalled products contain an incorrect version of the Instructions for Use that includes language beyond what was authorized in the FDA's 510(k) clearance.
The firm discovered this discrepancy and is replacing the affected products with corrected instructions. Approximately 9,200 units were distributed nationwide.
Consumers with affected products should contact CellEra LLC to obtain the correct instructions for use.
The recalled product
- Product
- 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
- Manufacturer
- CellEra LLC
- Hazard
- labeling-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot 229999 GTIN 10856276008762
- 00856276008765
- 00856276008758
Distribution
Distributed nationwide across the United States.
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