ChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss
CareFusion 213, LLC is recalling ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol applicators distributed nationwide because unsterilized units intended for further processing were distributed through the wrong channels.
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 distributed with lack of sterility assurance. The product is a topical antiseptic intended for medical use where sterility is critical to patient safety, meeting the Severe criteria.
Plain-English summary
CareFusion 213, LLC is recalling ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol), 500 x 1 mL applicators per case, NDC 54365-400-31, catalog number 930480NSB. The recall affects approximately 18,000 units distributed nationwide in the USA. Specific lot numbers affected include 4088933 (expiration 03/31/2027), 4177711, 4195438 (06/30/2027), 5051114 (02/29/2028), 5070540 (03/31/2028), 5106254 (04/30/2028), 5141607 (05/31/2028), and 5196494 (07/31/2028).
The recall was initiated because unsterilized ChloraPrep applicators intended for further processing and sterilization were distributed to customers outside of the intended distribution channel. These products lack assurance of sterility.
Customers who have received affected units should stop use and contact CareFusion 213, LLC for instructions on return or disposal of the product. Healthcare providers and patients should not use applicators from the affected lots.
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-channel-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 (15)
- Lot: 4088933
- Exp 03/31/2027
- 4177711
- 4195438
- Exp 06/30/2027
- 5051114
- Exp 02/29/2028
- 5070540
- Exp 03/31/2028
- 5106254
- Exp 04/30/2028
- 5141607
- Exp 05/31/2028
- 5196494
- Exp 07/31/2028.
Distribution
Distributed nationwide across the United States.
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