Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
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📍Recalling firmCarefusion 213, Llc1550 Northwestern Dr · El Paso, TX 79912-8000
✎ GovInfoNow plain-language explainer
CareFusion 213, LLC is recalling ChloraPrep One-Step Patient Preoperative Skin Preparation because the firm mistakenly released quarantined material that failed sterility testing. This means the applicators may not be sterile as labeled. The recall affects 576 cartons distributed to Illinois, Missouri, and New Jersey. Read more at govinfonow.com/recall/48918-carefusion-213-llc-recalls-chloraprep-one-step-2-w-v.
“ChloraPrep Recall: Non-Sterile Preoperative Skin Prep.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48918-carefusion-213-llc-recalls-chloraprep-one-step-2-w-v. Based on FDA recall #D-004-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-004-2013%22&limit=1).
The FDA announced on April 23, 2012, that CareFusion 213, LLC is recalling ChloraPrep One-Step Patient Preoperative Skin Preparation due to a lack of assurance of sterility. The agency said the firm mistakenly released quarantined material that failed sterility testing.
How to tell if you have it
Brand: ChloraPrep
Product: ChloraPrep One-Step Skin Prep
Lot: 52894
Product Code: 260400
NDC: 54365-400-01
The hazard
The recall addresses the risk posed by quarantined, non-conforming material that failed sterility testing. The firm mistakenly released this material, resulting in a lack of assurance of sterility for the product.
Context
GovInfoNow's records show CareFusion 213, LLC has had 16 other recalls on record since November 8, 2011. Other recent recalls of similar products include BD ChloraPrep Clear 60x1mL (July 9, 2026), BD ChloraPrep Scrub Teal Recall (June 11, 2026), and BD ChloraPrep Clear 1mL Applicator Recall (May 28, 2026). Other recent recalls of similar products include Sterile Lubricant Dry Eye Relief Eye Drops (September 11, 2026), Bio Glo Fluorescein Sodium Ophthalmic Strips Recall (December 31, 2025), and Carolina Infusion Recalls Quad-Mix Injectable (September 10, 2026).
How to tell if you have this one
Look for ChloraPrep One-Step Patient Preoperative Skin Preparation, 3mL Applicators, sold in cartons of 25. Check the lot number on the packaging; the recalled lot is 52894. The product code is 260400 and the NDC is 54365-400-01.
Brand
ChloraPrep
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop using the product
Do not use any ChloraPrep One-Step applicators from the recalled lot because they may not be sterile.
Check your inventory
Verify if you have product code 260400, NDC 54365-400-01, and lot number 52894.
Contact the manufacturer
The record does not specify a remedy or return process; contact CareFusion 213, LLC for further instructions.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “IL, MO, and NJ” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Missouri, New Jersey.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-004-2013 (April 23, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-004-2013 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.