Calcium Alginate Wound Dressings Recalled for Incorrect Instructions
CellEra LLC is recalling Vitale Silver calcium alginate dressings nationwide because packages contain incorrect Instructions for Use with language not approved by the FDA. The firm is providing replacement packages with corrected instructions.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class III recall involving incorrect labeling/documentation in the Instructions for Use, with no reported patient injuries or illnesses. FDA Class III recalls are typically low to moderate severity, and documentation/labeling issues without reported harm align with a Moderate classification.
Plain-English summary
CellEra LLC is recalling Vitale Silver calcium alginate dressings (model 20548, 4x8 inches, 5 per box) distributed nationwide. The recalled packages contain an incorrect version of the Instructions for Use that includes language not approved by the FDA as part of the product's 510(k) clearance.
Approximately 11,770 units were distributed, identified by lot numbers 212299 and 200999. The product was distributed nationwide in the United States.
Consumers and healthcare facilities should stop using the product with the incorrect instructions and contact CellEra LLC for replacement packages containing the corrected Instructions for Use.
The recalled product
- Product
- 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
- Manufacturer
- CellEra LLC
- Hazard
- Affected units
- 11,770
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 (4)
- Lot 212299
- 200999 GTIN 10850005565250
- 00850005565253
- 00850005565246
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by CellEra LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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