FDAFDA · Food and drugs·Recall number D-227-2013
Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260307, NDC 54365-200-99, CareFusion, Leawood, KS 66211.
Published April 3, 2013 · Recall initiated: March 4, 2013
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
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CareFusion 213, LLC
- Distributor
- Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
- Lot
- All lots with expiry between 12/11 to 10/15.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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