Carefusion Recalls ChloraPrep Skin Preparation Due to Sterility Failure
Carefusion 213, LLC is recalling ChloraPrep One-Step skin preparation applicators because quarantined material failed sterility testing. The affected product was distributed in Illinois, Missouri, and New Jersey.
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: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility for a medical device used on patients, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
Carefusion 213, LLC is recalling 576 cartons of ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators. The recall is due to a lack of assurance of sterility, as the firm mistakenly released quarantined, non-conforming material that had failed sterility testing.
The affected product is identified by Lot 52894 and Product Code 260400. The distribution pattern for this recall includes Illinois, Missouri, and New Jersey. The product is a single-use, latex-free applicator intended for preoperative skin preparation.
Consumers and healthcare facilities should check their inventory for the specific lot and product code listed above. If the product is found, it should be removed from use and returned to the supplier or the recalling firm in accordance with their instructions.
The recalled product
- Product
- ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.
- Manufacturer
- Carefusion 213, Llc
- Affected units
- 576
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 52894
- Product Code: 260400
Distribution
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