Surgical skin antiseptic recalled due to open seal on sterile applicators
ChloraPrep One-Step surgical antiseptic applicators are being recalled nationwide because some packages have open seals that could compromise sterility. Non-sterile applicators may pose a risk during surgical skin preparation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or hospitalizations. The open seal on sterile surgical-prep applicators represents a risk-of-harm product where injury has not been reported, meeting the Score 3 criterion.
Plain-English summary
ChloraPrep One-Step is a sterile surgical skin antiseptic containing 2% chlorhexidine gluconate and 70% isopropyl alcohol, manufactured by CareFusion 213, LLC, a subsidiary of Becton, Dickinson and Company. The recall involves 385,200 applicators distributed nationwide, with lot numbers 3354127 and 3350974 (expiration date 12/31/2026).
The FDA initiated this Class II recall because the product packaging may have open seals on the applicator pouches. An open seal on sterile product packaging creates an assurance-of-sterility issue that could allow contamination.
Healthcare facilities and consumers who have the affected lots should discontinue use immediately. Contact the manufacturer or the FDA for guidance on return procedures and product replacement.
The recalled product
- Product
- CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- CHLORAPREP ONE-STEP
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Surgical Antiseptic
- Hazard
- open-seal
- sterility-failure
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 #s: 3354127 and 3350974
- Exp Date: 12/31/2026
Distribution
Distributed nationwide across the United States.
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