CareFusion Recalls Preoperative Skin Prep Products Due to Sterility Labeling Error
CareFusion is recalling Sepp Compound Benzoin Tincture products because labeling incorrectly implies the antiseptic solution is sterile, when only the applicator is sterile.
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: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a labeling error regarding sterility claims rather than a direct contamination or defect.
Plain-English summary
CareFusion 213, LLC is recalling Sepp Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk, which are used as preoperative skin products. The recall involves 13,749,000 units distributed nationwide in the United States.
The recall was initiated after an internal review found that the product labeling states the contents are sterile without clarifying that this claim applies only to the applicator. The antiseptic solution itself is a cutaneous disinfectant and is not sterilized.
This labeling error could lead to confusion regarding the sterility of the solution. Consumers and healthcare providers should stop using the affected products and contact CareFusion for further instructions.
The recalled product
- Product
- Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
- Manufacturer
- CareFusion 213, LLC
- Hazard
- Affected units
- 13,749,000
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)
- Tincture Packaged: Product Number 260619 and Product ID D086353
- Tincture 3
- 000 Bulk: Product Number 260520 and Product ID D086353.
Distribution
Distributed nationwide across the United States.
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