FDAFDA · Food and drugs·Recall number D-004-2013
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.
Published October 10, 2012 · Recall initiated: April 23, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carefusion 213, Llc
- Distributor
- IL, MO, and NJ
- Lot
- Lot 52894, Product Code: 260400
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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