Blood Culture Prep Kit II containing 1 FREPP recall: Sterility Concern
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.
Why was Blood Culture Prep Kit II containing 1 FREPP 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots with expiry between 12/11 to 10/15.
- Product
- 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.
- Recalling firm
- CareFusion 213, LLC
- Quantity
- 929,000 kits
- Distribution
- Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
- Recall date
- April 3, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)