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.
Reported: April 3, 2013 Initiated: March 4, 2013 #D-228-2013
Product Description
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.
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.
Details
- Recalling Firm
- CareFusion 213, LLC
- Units Affected
- 46,500 kits
- Distribution
- Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
- Location
- El Paso, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by CareFusion 213, LLC. Units affected: 46,500 kits.
Why was this product recalled? ▼
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 3, 2013. Severity: Moderate. Recall number: D-228-2013.
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