Medline has issued a recommendation for customers to remove certain convenience kits from use or sale due to a potential sterility breach in included BD ChloraPrep Clear and FREPP Clear applicators, as announced by the U.S. Food and Drug Administration (FDA). This action is part of the Medical Device Recalls and Early Alerts Program.
The issue stems from a Drug Recall by Becton, Dickinson and Company for specific lots of BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators. Medline said this recall is "due to a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area." A compromised sterile barrier could expose patients and users to microbial contamination.
Potential health consequences range from no injury to localized or more serious infections requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly for critically ill or immunocompromised patients, severe infection could become life-threatening. As of June 12, Medline has reported no serious injuries or deaths associated with this issue.
Patients who may have been exposed should be monitored according to clinical judgment for signs or symptoms of infection, and any suspected infection should be evaluated and treated promptly. Patients without complications do not require follow-up.