CellEra Recalls VITALE Silicon Foam Dressings Due to Adhesive Defect
CellEra LLC is recalling 2,110 units of VITALE Silicon Foam Dressings because the adhesive border was not sticky enough.
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: The recall is classified as FDA Class II, and the defect (insufficient stickiness) is a functional issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
CellEra LLC is recalling 2,110 units of VITALE Silicon Foam Dressings 4"x4" (Cat. No. 20144). The recall was initiated because the adhesive border on the dressings was not sticky enough.
The affected products are identified by Lot # 161616 and HIBCC bar code M6692014409. These units were distributed in Ohio, Pennsylvania, and Virginia.
Consumers who have these specific dressings should stop using them and contact CellEra LLC for further instructions.
The recalled product
- Product
- VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
- Manufacturer
- CellEra LLC
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 2,110
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 (1)
- Lot # 161616 Cat. No. 20144 HIBCC bar code was M6692014409
Distribution
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