Recalls / Class II
Class IID-229-2013
Product
FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per kit, packaged in 20 kits per carton, Cat. No 260288, NDC 54365-202-99, CareFusion, Leawood, KS 66211.
- Affected lot / code info
- All lots with expiry between 07/11 to 08/14.
Why it was 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.
Recalling firm
- Firm
- CareFusion 213, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1550 Northwestern Drive, El Paso, Texas 79912-8000
Distribution
- Quantity
- 544,500 kits
- Distribution pattern
- Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
Timeline
- Recall initiated
- 2013-03-04
- FDA classified
- 2013-03-28
- Posted by FDA
- 2013-04-03
- Terminated
- 2014-05-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-229-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.