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Early Alert: Convenience Kits Issue from Medline
The FDA is aware that Medline has issued a letter to affected customers recommending certain convenience kits be removed from where they are used or sold.
Medline stated that Becton, Dickinson and Company is conducting a Drug Recall of specific lots of the BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators due to a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening. 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 who may have been exposed without complications do not require follow up.
As of June 12, Medline has reported no serious injuries or no deaths associated with this issue.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Medline at recalls@medline.com or 866-359-1704.
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