Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
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Contact the company
📍Recalling firmCarefusion 213, Llc1550 Northwestern Dr · El Paso, TX 79912-8000
✎ GovInfoNow plain-language explainer
CareFusion 213, LLC is recalling specific units of ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator because they may not be sterile. The recall was initiated after a customer complaint reported that some individual unit packaging had incomplete or open seals. This affects approximately 67,775 applicators distributed nationwide. Read more at govinfonow.com/recall/48963-carefusion-213-llc-recalls-chloraprep-with-tint-hi-lite-orange.
“ChloraPrep Recall: Non-Sterile Skin Prep Applicators.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48963-carefusion-213-llc-recalls-chloraprep-with-tint-hi-lite-orange. Based on FDA recall #D-1674-2012 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1674-2012%22&limit=1).
CareFusion 213, LLC voluntarily recalled ChloraPrep with Tint Applicators on Nov. 8, 2011, after the FDA announced a sterility hazard due to incomplete packaging seals. The recall affects 67,775 units distributed nationwide.
How to tell if you have it
Brand: ChloraPrep
Product: ChloraPrep with Tint Applicator
Product code: 260415
Lot#: 48225
The hazard
The FDA reported that some units had incomplete seals, or open seals, on the individual unit packaging, creating a lack of assurance of sterility. This hazard was identified following a customer complaint.
Context
GovInfoNow's records show CareFusion 213, LLC has issued 16 other recalls since April 23, 2012. Recent related recalls include BD ChloraPrep Clear on July 9, 2026, and BD ChloraPrep Scrub Teal on June 11, 2026, both citing lack of assurance of sterility. Other recent recalls of similar products include Sterile Lubricant Dry Eye Relief Eye Drops (Sept. 11, 2026) and Thea Pharma Similasan Eye Drops (April 23, 2026).
How to tell if you have this one
Check for ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator with product code 260415 and lot number 48225. The manufacturer is CareFusion 213, LLC of Leawood, KS.
Brand
ChloraPrep
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop using the product
Do not use any applicators with product code 260415 and lot number 48225 due to potential lack of sterility.
Contact manufacturer for details
The recall record does not specify a return or replacement process; contact CareFusion 213, LLC for further instructions.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 18 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-1674-2012 (November 8, 2011) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1674-2012 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.