FDA-Drug2012-09-26Class II
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
Hazard
Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Sold states
Nationwide
Affected count
67,775 Applicators
Manufactured in
1550 Northwestern Dr, El Paso, TX, United States
Products
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1674-2012More Carefusion 213, Llc recalls
- FDA-Drug2026-07-22BD ChloraPrep Clear skin antiseptic recalled for potential sterility packaging defect
- FDA-Drug2026-07-08BD ChloraPrep Hi-Lite Orange recalled for lack of sterility assurance
- FDA-Drug2026-07-08CareFusion ChloraPrep FREPP applicators recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep CLear skin antiseptic recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep CLear skin antiseptic recalled for lack of sterility assurance
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