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

Carefusion 213, Llc
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-1674-2012

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