Medline Industries, LP — Class II: Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG
Medline Industries, LP has initiated a Class II recall for specific convenience kits containing Swan-Ganz catheters manufactured by Becton Dickinson (BD). The recall is due to reports of leaks, damage, and breakage involving the blue proximal injectate lumen hub on the catheters.
This affects Medline Industries, LP, healthcare providers utilizing CABG and RN CDS convenience kits (specifically DYNJ905855, DYNJ905857, and DYNJ905936B), and quality compliance teams managing third-party component risks.快速
This recall highlights the regulatory complexity of 'convenience kits' where a primary manufacturer's component failure necessitates a secondary recall by the kit assembler. The reported failure mode (lumen breakage) presents clinical risks including infection, medication loss, and blood loss, suggesting that kit assemblers must maintain robust traceability and rapid response mechanisms for integrated third-party medical devices.
QA and supply chain teams should immediately identify and quarantine specific Kit Germantown/University CABG and OH MED RN CDS product codes. Regulatory departments should verify that internal recall procedures account for sub-component failures from third-party manufacturers. Clinical risk assessments should be updated to reflect potential leakage or breakage risks associated with the blue proximal injectate lumen hub.
Class II. Reason: Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.. Product: Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
Open in openFDA / FDA.gov