Medline Industries, LP — Class II: Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ9
Medline Industries, LP has initiated a Class II recall for specific Cardiac Major convenience kits because they contain Swan-Ganz catheters previously recalled by Becton Dickinson (BD). The BD catheters were found to have failures in the proximal injectate lumen hub, resulting in leaks, breakage, and potential clinical risks such as infection or blood loss.
Medline Industries, clinical facilities using specialized cardiac surgical kits, and supply chain or quality personnel responsible for monitoring component-level recalls in kitted products.
This action highlights the regulatory risk for kit manufacturers (convenience kit assemblers) when a third-party component undergoes a safety recall. Regulatory teams should note that a failure in a single sub-component necessitates a recall of the entire finished kit. The reported mechanical failures (breakage and leakage) suggest a significant risk to procedural integrity and patient safety if these kits remain in circulation.
Identify and quarantine all affected Medline Cardiac Major convenience kits. Verify the specific catalog numbers against current inventory and contact the manufacturer for return/disposal instructions. Review internal quality systems for managing third-party component recalls to ensure downstream notification processes are effective.
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 CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
Open in openFDA / FDA.gov