The Recall Desk

FDA (Drugs) recall action 64583

CareFusion 213, LLC recalled 6 products on 2013-04-03

The FDA (Drugs) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2013-04-03
Critical
0
Units
14,210,000

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–6 of 6

  • ModerateFDA (Drugs)··2013-04-03

    CareFusion Recalls FREPP/SEPP Kits Due to Misleading Sterility Labeling

    CareFusion 213, LLC is recalling 544,500 FREPP/SEPP kits because the product is not sterile, but the labeling misleadingly implies it is.

    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.
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2013-04-03

    CareFusion Recalls Misbranded Isopropanol Applicators Due to Sterility Labeling

    CareFusion 213, LLC is recalling 698,000 SEPP 70% Isopropanol applicators because the product is not sterile, making the labeling misleading regarding sterility claims.

    Product
    SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170-01, CareFusion, Leawood, KS 66211.
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2013-04-03

    CareFusion Blood Culture Prep Kits Recalled for Misleading Sterility Labeling

    CareFusion is recalling Blood Culture Prep Kit II units because the product is not sterile, making the labeling misleading regarding sterility claims.

    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.
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2013-04-03

    CareFusion Recalls Povidone Iodine Applicators Due to Sterility Labeling Errors

    CareFusion is recalling SEPP 10% Povidone Iodine Solution applicators because the product is not sterile, making the sterility claims on the label misleading.

    Product
    SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, CareFusion, Leawood, KS 66211, Cat. No 260286, NDC 54365-145-01; and b) 3000-count applicators per case, Cat. No…
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2013-04-03

    CareFusion Recalls Donor Prep Kits Due to Misleading Sterility Labeling

    CareFusion 213, LLC is recalling 46,500 Donor Prep Kits because the labeling is misleading regarding sterility claims. The product is not sterile.

    Product
    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.
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2013-04-03

    CareFusion Recalls SEPP 2% Iodine Tincture Applicators for Sterility Mislabeling

    CareFusion 213, LLC is recalling SEPP 2% Iodine Tincture applicators because the product is not sterile, making the labeling misleading regarding sterility claims.

    Product
    SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, Cat. No 260261, NDC 54365-161-01, CareFusion, Leawood, KS 66211; b) 3000-count applicators (Net…
    Category
    Distribution
    2 states