Calcium alginate wound dressings recalled for incorrect instruction labeling
CellEra LLC is recalling Vitale Silver calcium alginate dressings because the included Instructions for Use contain language exceeding FDA clearance. The firm is replacing affected units with correct instructions.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall involving a documentation error in the Instructions for Use. No illnesses, injuries, or deaths have been reported, and the issue is correctable through provision of accurate instructions. FDA Class III recalls are typically scored 1 or 2.
Plain-English summary
CellEra LLC is recalling the 20545 Vitale Silver calcium Alginate Dressings (4x5 size, 10 dressings per box) due to incorrect labeling in the Instructions for Use (IFU). The included IFU contains language that goes beyond what was approved in the product's FDA 510(k) clearance submission.
The recall affects approximately 17,850 units distributed nationwide. The affected batch is Lot 212299 (GTINs: 10856276008700, 00865276008703, 00856276008697).
No injuries or adverse events have been reported. Consumers in possession of these dressings should contact CellEra LLC for replacement instructions or a replacement product. The firm is replacing affected units with the correct IFU.
The recalled product
- Product
- 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
- Manufacturer
- CellEra LLC
- Category
- Medical Device — Wound Dressing
- Hazard
- Affected units
- 17,850
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 212299 GTIN 10856276008700
- 00865276008703
- 00856276008697
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.
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