CareFusion Recalls FREPP/SEPP Kits Due to Misleading Sterility Labeling
CareFusion 213, LLC is recalling 544,500 FREPP/SEPP kits because the product is not sterile, but the labeling misleadingly implies it is.
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, which typically involves a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error regarding sterility, which fits the criteria for a moderate severity recall involving minor labeling errors or low-risk contamination issues.
Plain-English summary
CareFusion 213, LLC is voluntarily recalling 544,500 kits of FREPP/SEPP. Each kit contains one FREPP (povidone iodine 2% aqueous solution) and one SEPP (povidone iodine 10% USP). The affected products are identified by Catalog Number 260288 and NDC 54365-202-99, and include all lots with expiration dates between July 2011 and August 2014.
The recall was initiated because the product is misbranded. Specifically, the product is not sterile, yet the labeling is misleading regarding sterility claims. This discrepancy could lead users to believe the product meets sterility standards it does not actually meet.
The affected kits were distributed nationwide, as well as in Puerto Rico, the Virgin Islands, Malaysia, and the United Kingdom. Consumers and healthcare providers should check their inventory for these specific lot and expiration date ranges. If the product is found, it should be returned to the supplier or CareFusion 213, LLC for credit or replacement.
The recalled product
- Product
- FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per kit, packaged in 20 kits per carton, Cat. No 260288, NDC 54365-202-99, CareFusion, Leawood, KS 66211.
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Antiseptic / Topical
- Hazard
- Affected units
- 544,500
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 07/11 to 08/14.
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.
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