CareFusion ChloraPrep FREPP applicators recalled for lack of sterility assurance
What this means
CareFusion distributed unsterilized ChloraPrep FREPP applicators (chlorhexidine gluconate and isopropyl alcohol solution) to customers outside their intended distribution channel. These applicators were meant for further processing and sterilization before use, but were shipped to end users without that sterilization step, creating a risk of infection if used on patients.
- Check if you have ChloraPrep FREPP applicators with lot numbers 3279063, 3319524, 3324094, 3343541, 3357638, 4010202, 4206771, 4267824, 4270191, 4282285, 4338352, 5053657, or 5121340.
- Do not use affected applicators for patient care.
- Contact CareFusion or your supplier for instructions on return or replacement.
The agency's original wording
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0646-2026More CareFusion recalls
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