Reported May 5, 2021 · Terminated
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile…
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?
- BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415
- Lot codes and dates
- Lot and Exp Date
164 of 164 codes
001857811/30/202200582772/28/202300591412/28/202300663652/28/202300672893/31/202300708663/31/202300740383/31/202300760343/31/202300846193/31/202300861583/31/202300908943/31/202300939033/31/202300958383/31/202300975613/31/202300984703/31/202301003832/28/202301096324/30/202301111854/30/202301133394/30/202301158534/30/202301219824/30/202301221924/30/202301221934/30/202301221944/30/202301288214/30/202301294094/30/202301352874/30/202301570835/31/202301612195/31/202301640326/30/2023
- Lot and Exp Date
- Amount recalled
- 14,275,400 cartons
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
This product could cause temporary or reversible health problems — stop using it.
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