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.
Reported: April 3, 2013 Initiated: March 4, 2013 #D-229-2013
Product Description
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.
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
- 544,500 kits
- Distribution
- Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
- Location
- El Paso, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by CareFusion 213, LLC. Units affected: 544,500 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-229-2013.
Related Recalls
NHTSA Critical
LEXUS 2025: POWER TRAIN:AUTOMATIC TRANSMISSION
LEXUS · 2026-02-18
NHTSA Critical
CADILLAC,CHEVROLET,GMC 2022: POWER TRAIN:AUTOMATIC TRANSMISSION:CONTROL MODULE:SOFTWARE
CADILLAC,CHEVROLET,GMC · 2026-02-13
NHTSA Critical
CHEVROLET,GMC 2020-2022: POWER TRAIN:AUTOMATIC TRANSMISSION:CONTROL MODULE:SOFTWARE
CHEVROLET,GMC · 2026-02-12
NHTSA Critical
CADILLAC 2024: BACK OVER PREVENTION:SOFTWARE
CADILLAC · 2026-02-12
NHTSA Critical
NISSAN 2024-2025: FUEL SYSTEM, GASOLINE:FUEL INJECTION SYSTEM:THROTTLEBODY/MANIFOLD
NISSAN · 2026-02-12