Medical device wound dressing recall for incorrect instructions
CellEra LLC is recalling Vitale Silver calcium Alginate Dressings because product packages contain incorrect Instructions for Use with language beyond FDA 510(k) clearance scope. The firm is replacing affected units with correct 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 1/5 (Low).
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 for an instructions/documentation error with no reported illnesses or injuries and no physical product defect. Per the rubric, FDA Class III recalls are typically scored 1 or 2; documentation issues without reported harm fall in the Low category.
Plain-English summary
CellEra LLC is recalling Vitale Silver Calcium Alginate Dressings (lot 206999), which were distributed nationwide. The affected packages contain an incorrect version of the Instructions for Use (IFU) with language that goes beyond the scope of the cleared 510(k) submission.
The manufacturer discovered that the incorrect IFU had been inserted into the affected products. CellEra LLC is replacing these products with units containing the correct version of the IFU.
The recalled product
- Product
- 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
- Manufacturer
- CellEra LLC
- Category
- Medical Device — Wound Dressing
- Hazard
- Affected units
- 4,400
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 206999 GTIN 10856276008663
- 00856276008666
- 00856276008659
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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