CareFusion Recalls Donor Prep Kits Due to Misleading Sterility Labeling
CareFusion 213, LLC is recalling 46,500 Donor Prep Kits because the labeling is misleading regarding sterility claims. The product is not sterile.
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 due to misleading labeling regarding sterility. This fits the 'Moderate' rubric for labeling errors where the hazard is primarily related to misbranding rather than a direct, high-risk contamination or injury report.
Plain-English summary
CareFusion 213, LLC is voluntarily recalling 46,500 Donor Prep Kits. The kits contain one FREPP (70% isopropyl alcohol) and one SEPP (iodine tincture 2% USP). The recall is due to a labeling issue where the product is not sterile, but the labeling is misleading in relation to sterility claims.
The affected product is identified by Catalog Number 260311 and NDC 54365-201-99. The recall includes all lots with expiry dates between 09/11 and 09/13. The product was distributed nationwide, as well as in Puerto Rico, the Virgin Islands, Malaysia, and the United Kingdom.
Consumers should check their inventory for these specific kits and stop using them if they match the description. The FDA has classified this as a Class II recall, indicating a situation that may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260311, NDC 54365-201-99, CareFusion, Leawood, KS 66211.
- Manufacturer
- CareFusion 213, LLC
- Affected units
- 46,500
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)
- All lots with expiry between 09/11 to 09/13.
Distribution
Part of a larger recall action
This product is one of 6 recalled by CareFusion 213, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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