Medline Industries, LP — Class II: Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2)
Medline Industries, LP is recalling specific pediatric and connector blood culture kits due to potential sterility breaches in included BD ChloraPrep and FREPP applicators. The risk stems from wrinkles in the paper lidding that may extend into the seal area, potentially compromising the sterile barrier.
Medline Industries, LP, healthcare providers utilizing pediatric blood culture trays, and supply chain/QA professionals responsible for kit integrity and sterile barrier maintenance.
A compromised sterile barrier in a blood culture kit presents a significant risk of microbial contamination. While the source suggests injuries may be localized, the potential for life-threatening infections in immunocompromised or pediatric populations necessitates immediate containment and highlights the regulatory risks associated with component integration in convenience kits.
Identify and quarantine affected pediatric and connector blood culture kits (Models DYNDH1193 and DYNDH1487A). Review incoming inspection protocols for kit components to identify packaging defects like lidding wrinkles, and evaluate supplier quality management for third-party sterile applicators.
Class II. Reason: The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have 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.. Product: Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, Model Number: DYNDH1487A. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
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