Reported Sep 26, 2012 · Terminated

ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only,…

Carefusion 213, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Carefusion 213, Llc · 1550 Northwestern Dr · El Paso, TX · 79912-8000

Is this the product you have?

  • 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
Lot codes and dates
    • Product code 260415
    • Lot#: 48225
Amount recalled
67,775 Applicators

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 23, 2013 · Data as of Sep 19, 6:25 PM UTC

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