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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 52894, Product Code: 260400
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Carefusion 213, Llc
- Reason for Recall:
- Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Lot 52894, Product Code: 260400
Distribution:
Distributed in: IL, MO, NJ
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-004-2013
Related Recalls
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.