ChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, creating a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterile pharmaceutical product (topical antiseptic preparation) distributed with lack of sterile assurance due to distribution outside the intended channel. The failure of sterility assurance in a topical drug product intended for skin preparation before medical procedures meets the Severe criterion for Class II recalls with potential for significant harm.
Plain-English summary
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v) applicators, NDC 54365-400-34, Lot 4190081, Exp 06/30/2027. The product was distributed nationwide in the USA.
The applicators were intended for further processing and sterilization but were instead distributed to customers outside the intended distribution channel. This distribution error means that unsterilized units reached customers who expected sterile product.
Consumers or healthcare facilities who received this product should stop using it and contact their supplier or CareFusion 213, LLC for instructions on return or proper handling.
The recalled product
- Product
- CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- CHLORAPREP ONE-STEP
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Topical Antiseptic
- Hazard
- lack-of-sterility
- distribution-error
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 (2)
- Lot: 4190081
- Exp 06/30/2027
Distribution
Distributed nationwide across the United States.
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