FDAFDA · Food and drugs·Recall number D-1674-2012
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
Published September 26, 2012 · Recall initiated: November 8, 2011
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: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carefusion 213, Llc
- Distributor
- Nationwide
- Lot
- Product code 260415, Lot#: 48225
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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