CareFusion 213, LLC Recall: ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 7
CareFusion 213, LLC Recall: ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 7 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: CareFusion 213, LLC; Product: ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Cl
| Recalling firm | CareFusion 213, LLC |
|---|---|
| Product | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400 |
| Reason for recall | Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | Distributed Nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, Brazil. |
| Recall initiated | 20210319 |
| Recall number | D-0345-2021 |
| Category | drug |
| State | TX |
| Country | United States |
$29/mo
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