CareFusion 213, LLC is recalling ChloraPrep With Tint, a 26 mL skin antiseptic applicator containing chlorhexidine gluconate and isopropyl alcohol. The recall addresses a lack of assurance that the product pouches are properly sealed, which compromises sterility. This specific batch affects approximately 23,000 units distributed nationwide. Read more at govinfonow.com/recall/47451-carefusion-213-llc-recalls-chloraprep-with-tint-2-w-v.
“ChloraPrep Recall: Sterility Risk in 26 mL Applicators.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/47451-carefusion-213-llc-recalls-chloraprep-with-tint-2-w-v. Based on FDA recall #D-1442-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1442-2014%22&limit=1).
The FDA announced on June 13, 2013, that CareFusion 213, LLC voluntarily recalled ChloraPrep With Tint Applicators due to a lack of sterility assurance. The agency classified the recall as Class II.
How to tell if you have it
Brand: ChloraPrep
Product: ChloraPrep With Tint Applicator
NDC: 054365-400-13
Lot #: 71132
Expiry: 02/2017
Size: 26 mL
The hazard
The recall addresses the risk that immediate product pouches may not be properly sealed, leading to a lack of assurance of sterility. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show CareFusion 213, LLC has 16 other recalls on record since November 8, 2011. Other recent recalls of similar products include BD ChloraPrep Clear 60x1mL (July 9, 2026), CareFusion BD ChloraPrep Hi-Lite Orange (June 11, 2026), and CareFusion BD ChloraPrep Clear 1mL Applicator (May 28, 2026).
How to tell if you have this one
Check your applicator for the following details: Brand is ChloraPrep With Tint, Hi-Lite Orange color; NDC is 054365-400-13; Lot number is 71132; Expiration date is 02/2017. The product contains 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol in a 26 mL applicator.
Brand
ChloraPrep
Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 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-1442-2014 (June 13, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1442-2014 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.