CareFusion Blood Culture Prep Kits Recalled for Misleading Sterility Labeling
CareFusion is recalling Blood Culture Prep Kit II units because the product is not sterile, making the labeling misleading regarding sterility claims.
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, but the source text identifies the issue as a labeling error (misbranding) without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
CareFusion 213, LLC is voluntarily recalling 929,000 kits of Blood Culture Prep Kit II. The product, which contains isopropyl alcohol and iodine tincture, is being recalled because it is misbranded. Specifically, the product is not sterile, yet the labeling is misleading in relation to sterility claims.
The affected units are packaged in 20-count kits per carton (Cat. No 260307, NDC 54365-200-99). The recall includes all lots with expiry dates between December 2011 and October 2015. Distribution was nationwide, as well as in Puerto Rico, the Virgin Islands, Malaysia, and the United Kingdom.
Consumers and healthcare facilities should stop using the affected kits and contact CareFusion for further instructions or a refund.
The recalled product
- Product
- Blood Culture Prep Kit II 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 260307, NDC 54365-200-99, CareFusion, Leawood, KS 66211.
- Manufacturer
- CareFusion 213, LLC
- Hazard
- Affected units
- 929,000
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 (1)
- All lots with expiry between 12/11 to 10/15.
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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