Reported Oct 10, 2012 · Terminated
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin…
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 One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.
- Lot codes and dates
- Lot 52894
- Product Code260400
- Amount recalled
- 576 Cartons
Where it was sold
Why it was recalled
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
This product could cause temporary or reversible health problems — stop using it.
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