FDA (Drugs) recall action 99217
The FDA (Drugs) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, creating a lack of assurance of sterility.
CareFusion 213, LLC is recalling ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol applicators distributed nationwide because unsterilized units intended for further processing were distributed through the wrong channels.
CareFusion 213, LLC is recalling 7,650 units of ChloraPrep One-Step antiseptic applicators distributed nationwide because unsterilized product intended for further processing was distributed through incorrect channels.
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators distributed nationwide. The products were unsterilized and distributed outside the intended channel intended for further processing and sterilization.
CareFusion 213, LLC is recalling PurPrep sterile applicators distributed nationwide because unsterilized units intended for further processing were distributed to customers outside the intended channel.
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators that were intended for sterilization but were instead distributed unsterilized to customers outside the intended distribution channel.
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators nationwide because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, lacking sterility assurance.
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, creating a lack of sterility assurance.
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators distributed nationwide because unsterilized units intended for further processing were shipped to customers outside the intended distribution channel.
CareFusion is recalling ChloraPrep One-Step antiseptic applicators because unsterilized units intended for further processing were distributed outside the intended channel, creating a sterility assurance gap.