BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El…
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Read the official FDA notice →What to do
Stop using the product and check it against the description above. This recall is in the most serious category, meaning the agency believes it can cause serious injury or death — don't finish the package or use up what's left. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- CareFusion 213, LLC — El Paso, TX
- Severity
- Class I — serious
- Reported
- July 1, 2026
- Quantity
- 178,000 applicators
- Recall number
- D-0625-2026
- Status
- Ongoing
- Source
- FDA
Where it went
Nationwide inthe USA, as well as other foreign distribution.
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