CareFusion Recalls Povidone Iodine Applicators Due to Sterility Labeling Errors
CareFusion is recalling SEPP 10% Povidone Iodine Solution applicators because the product is not sterile, making the sterility claims on the label misleading.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 involves a labeling error regarding sterility claims without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
CareFusion 213, LLC is recalling SEPP 10% Povidone Iodine Solution USP applicators. The product is misbranded because it is not sterile, and the labeling is misleading regarding sterility claims.
The recall involves 8,960,000 applicators distributed nationwide, as well as in Puerto Rico, the Virgin Islands, Malaysia, and the United Kingdom. The affected lots include all units with expiry dates between 09/12 and 10/15, and all units with expiry dates between 10/11 and 07/14.
Consumers should stop using the product and contact CareFusion for further instructions or a refund.
The recalled product
- Product
- SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, CareFusion, Leawood, KS 66211, Cat. No 260286, NDC 54365-145-01; and b) 3000-count applicators per case, Cat. No…
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Topical Antiseptic
- Hazard
- Affected units
- 8,960,000
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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