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Medium RiskFDA Vet
Pets & Animals/Pet Medications

Carefusion 2200 Inc: Surgical Scrub Brushes Recalled for Low Iodine Concentration

Agency Publication Date: June 18, 2014
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Summary

Carefusion 2200 Inc. is recalling approximately 4.1 million Scrub Care Surgical Scrub Brushes and Nail Cleaners because the available iodine in the product is lower than what is stated on the label. This recall includes the 9% Povidone-iodine and 15% Povidone-iodine hand scrub variants, which fail to meet the required free iodine concentration for effective use. This product is primarily used as a veterinary surgical hand scrub to reduce the risk of infection. Consumers should contact their healthcare provider or the manufacturer regarding the next steps for these products.

Risk

If the iodine concentration is lower than labeled, the scrub may not effectively kill bacteria and microorganisms on the skin before surgery. This deficiency increases the risk of infection for animals undergoing medical procedures.

What You Should Do

  1. Check your supply of CareFusion Scrub Care Surgical Scrub Brushes for the following NDC numbers: 57613-003-18 (9% Povidone-iodine) or 57613-013-15 (15% Povidone-iodine).
  2. If you have the 9% scrub (Catalog 4451B), identify affected units by checking for lot numbers such as 0000503318 (Exp 2013-12), 0000506214 (Exp 2013-11), 0000520682 (Exp 2014-01), 0000545246 (Exp 2014-03), and 0000615762 (Exp 2014-11).
  3. If you have the 9% scrub (Catalog 4451GL), check for lot numbers including 0000511784 (Exp 2013-12), 0000552036 (Exp 2014-04), and 0000611309 (Exp 2014-10).
  4. If you have the 15% scrub (Catalog 4452B), check for lot numbers such as 0000503811 (Exp 2013-11), 0000538326 (Exp 2014-03), 0000566812 (Exp 2014-06), and 0000617388 (Exp 2014-11).
  5. Contact your healthcare provider, pharmacist, or veterinarian for guidance if these products were recently used in clinical settings.
  6. Return any unused, affected scrub brushes to the pharmacy or place of purchase for a refund.
  7. Contact CareFusion at their Vernon Hills, IL headquarters at 75 N Fairway Dr for further instructions or replacement information.
  8. For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund for unused product

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner with 9% Povidone-iodine (USP) Surgical Hand Scrub (30 brushes per carton)
Model:
Catalog Code 4451B
Catalog Code 4451GL
NDC 57613-003-18
Lot Numbers (51):
0000503318 (Exp 2013-12)
0000506214 (Exp 2013-11)
0000508533 (Exp 2013-11)
0000510764 (Exp 2013-11)
0000510935 (Exp 2013-11)
0000512731 (Exp 2013-12)
0000515176 (Exp 2013-12)
0000519658 (Exp 2013-12)
0000520682 (Exp 2014-01)
0000524275 (Exp 2014-01)
0000526893 (Exp 2014-01)
0000526894 (Exp 2014-01)
0000529734 (Exp 2014-01)
0000531474 (Exp 2014-02)
0000535988 (Exp 2014-02)
0000538311 (Exp 2014-02)
0000545246 (Exp 2014-03)
0000549924 (Exp 2014-04)
0000552624 (Exp 2014-04)
0000553607 (Exp 2014-04)
0000556017 (Exp 2014-04)
0000558355 (Exp 2014-05)
0000560447 (Exp 2014-05)
0000562700 (Exp 2014-05)
0000564519 (Exp 2014-05)
0000566810 (Exp 2014-05)
0000568880 (Exp 2014-06)
0000568881 (Exp 2014-06)
0000575374 (Exp 2014-06)
0000577556 (Exp 2014-07)
0000577571 (Exp 2014-07)
0000590828 (Exp 2014-08)
0000592582 (Exp 2014-08)
0000597039 (Exp 2014-09)
0000602710 (Exp 2014-09)
0000604890 (Exp 2014-10)
0000607065 (Exp 2014-10)
0000612905 (Exp 2014-11)
0000615356 (Exp 2014-11)
0000615762 (Exp 2014-11)
0000511784 (Exp 2013-12)
0000514626 (Exp 2013-12)
0000521710 (Exp 2014-01)
0000531476 (Exp 2014-02)
0000552036 (Exp 2014-04)
0000552623 (Exp 2014-04)
0000558356 (Exp 2014-05)
0000566811 (Exp 2014-05)
0000583939 (Exp 2014-07)
0000601031 (Exp 2014-09)
Date Ranges: Expires 2013-11, Expires 2013-12, Expires 2014-01, Expires 2014-02, Expires 2014-03, Expires 2014-04, Expires 2014-05, Expires 2014-06, Expires 2014-07, Expires 2014-08, Expires 2014-09, Expires 2014-10, Expires 2014-11
Product: CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner with 15% Povidone-iodine (USP) Surgical Hand Scrub (30 brushes per carton)
Model:
Catalog Code 4452B
NDC 57613-013-15
Lot Numbers:
0000503811 (Exp 2013-11)
0000506220 (Exp 2013-11)
0000510765 (Exp 2013-11)
0000512732 (Exp 2013-12)
0000515174 (Exp 2013-12)
0000517445 (Exp 2013-12)
0000521711 (Exp 2014-01)
0000524276 (Exp 2014-01)
0000526895 (Exp 2014-01)
0000529735 (Exp 2014-01)
0000531478 (Exp 2014-02)
0000535989 (Exp 2014-02)
0000538326 (Exp 2014-03)
0000540593 (Exp 2014-03)
0000542887 (Exp 2014-03)
0000547433 (Exp 2014-03)
0000549925 (Exp 2014-04)
0000553601 (Exp 2014-04)
0000554836 (Exp 2014-04)
0000560448 (Exp 2014-05)
0000562704 (Exp 2014-05)
0000564521 (Exp 2014-05)
0000566812 (Exp 2014-06)
0000568882 (Exp 2014-06)
0000568884 (Exp 2014-06)
0000575375 (Exp 2014-06)
0000586422 (Exp 2014-08)
0000588544 (Exp 2014-08)
0000592583 (Exp 2014-08)
0000601033 (Exp 2014-09)
0000602709 (Exp 2014-09)
0000604892 (Exp 2014-09)
0000607062 (Exp 2014-10)
0000607064 (Exp 2014-10)
0000612904 (Exp 2014-11)
0000615357 (Exp 2014-11)
0000615359 (Exp 2014-11)
0000617388 (Exp 2014-11)
Date Ranges: Expires 2013-11, Expires 2013-12, Expires 2014-01, Expires 2014-02, Expires 2014-03, Expires 2014-04, Expires 2014-05, Expires 2014-06, Expires 2014-08, Expires 2014-09, Expires 2014-10, Expires 2014-11

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 68217
Status: Resolved
Manufacturer: Carefusion 2200 Inc
Sold By: Medical distributors; Veterinary clinics; Authorized retailers
Manufactured In: United States
Units Affected: 2 products (1) Catalog Code 4451B: 1,939,500 hand scrubs; 2) Catalog Code 4451GL: 504,000 hand scrubs; 1,662,000 hand scrubs)
Distributed To: Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response