ChloraPrep One-Step Applicators Recalled Due to Compromised Sterile Packaging
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators nationwide because affected units may have open seals on the packaging, compromising sterility assurance.
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 loss of sterility assurance in a medical-use product (preoperative skin preparation). Loss of sterility in products intended for medical procedures presents a significant risk of serious infection, meeting the Severe criterion.
Plain-English summary
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate 2% and isopropyl alcohol 70%) patient preoperative skin preparation applicators nationwide. The affected product may exhibit an open seal on the applicator packaging, which can compromise the sterility assurance of the contents. The recall affects 385,200 applicators from lot numbers 3354127 and 3350974 with an expiration date of 12/31/2026, distributed nationwide in the U.S.
Consumers and healthcare facilities that have received affected product should stop using it and contact CareFusion 213, LLC or their distributor for instructions on return or replacement. The product is manufactured by CareFusion 213, LLC, a subsidiary of Becton, Dickinson and Co., located in El Paso, TX.
The recalled product
- Product
- CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- CHLORAPREP ONE-STEP
- Manufacturer
- CareFusion 213, LLC
- Hazard
- loss-of-sterility
- packaging-defect
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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