Class II
Terminated
Donor Prep Kit 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 260311, NDC 54365-201-99, CareFusion, Leawood, KS 66211.
- Company
- Carefusion 213, Llc
- Recall Initiated
- March 4, 2013
- Posted
- April 3, 2013
- Recall Number
- D-228-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 46,500 kits
- Firm Location
- El Paso, TX, United States
Reason for Recall
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Distribution
Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
Lot / Code Info
All lots with expiry between 09/11 to 09/13.
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