CareFusion 213, LLC recalled 106,400 units of ChloraPrep Triple Swabsticks on December 17, 2025. The recall occurred due to a lack of assurance of sterility. Consumers must stop using the product immediately and contact CareFusion for guidance.
Lack of Assurance of Sterlity
Consumers and healthcare providers should stop using this product immediately. Contact CareFusion 213, LLC or your healthcare provider for guidance. Notification method: Letter
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The recalled product is BD ChloraPrep Triple Swabsticks, containing Chlorhexidine gluconate (2% w/v) and Isopropyl alcohol (70% v/v). The lot number is 5086623 with an expiration date of March 31, 2028. The swabsticks were distributed nationwide in the United States.
The recall was issued due to a lack of assurance of sterility, which poses a risk of infection. As a Class II recall, it indicates a moderate risk to health.
There are no reported injuries or incidents associated with this recall. However, the potential risk of infection remains a significant concern.
Stop using the ChloraPrep Swabsticks immediately. Contact CareFusion 213, LLC or your healthcare provider for further guidance. A notification letter will be sent to customers.
For assistance, contact CareFusion at 1-800-XXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0243-2026.
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