Medline Industries, LP — Class II: Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U;
Medline Industries, LP has initiated a Class II recall for specific Major Procedure and Laparoscopy convenience kits due to the inclusion of a potentially contaminated component originally recalled by its manufacturer.
Medline Industries, LP, surgical centers, hospitals using convenience kits, and professionals in supply chain, quality assurance, and sterile processing.
This recall highlights the downstream regulatory risk associated with medical device convenience kits. When a sub-component manufacturer identifies a contamination issue, the kit assembler must manage a secondary recall for all finished goods containing that component. This suggests a potential vulnerability in supplier quality monitoring or traceability within the kit assembly process.
Inventory teams should immediately identify and sequester affected SKUs (CDS982040U, DYNJ89608, DYNJ903479L, DYNJ903479M). QA departments should review supplier notification protocols to ensure secondary recalls are triggered promptly when a sub-component manufacturer issues a recall.
Class II. Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer. Product: Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ903479L; 4) LAPAROSCOPY, Medline Kit SKU DYNJ903479M.. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
Open in openFDA / FDA.gov