ChloraPrep One-Step Antiseptic Solution Recall Due to Sterility Concerns
CareFusion is recalling 178,000 ChloraPrep One-Step antiseptic applicators (Lot #4073005) nationwide due to potential non-sterility from fungal contamination and seal breaches from paper lidding wrinkles.
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 FDA classified this as a Class I recall, which per the rubric requires a minimum score of 4. Although no illnesses or injuries are reported in the source text, the non-sterility hazard in a topical antiseptic product used in medical settings meets the Severe threshold for FDA Class I classification.
Plain-English summary
CareFusion 213, LLC is recalling BD ChloraPrep FREPP Clear 1.5 mL applicators (2% chlorhexidine gluconate and 70% isopropyl alcohol) in packages of 20, NDC 54365-400-30, Lot #4073005 with expiration date 03/31/2027. Approximately 178,000 applicators have been distributed nationwide and internationally.
The recall was initiated due to two sterility-related defects. The product may not be sterile due to the presence of Aspergillus penicillioides (a fungus). Additionally, wrinkles in the paper lidding may compromise the seal area, resulting in a lack of assurance of sterility.
ChloraPrep One-Step is used as a topical antiseptic. Non-sterile products used in medical settings pose a risk of infection. Consumers, healthcare providers, and facilities should stop using the recalled applicators immediately. Any product from Lot #4073005 should not be used. Contact CareFusion or the FDA with questions.
The recalled product
- Product
- CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- CHLORAPREP ONE-STEP
- Manufacturer
- CareFusion 213, LLC
- Hazard
- non-sterility
- fungal-contamination
- seal-breach
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 # 4073005
- Exp 03/31/2027
Distribution
Distributed nationwide across the United States.
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