Medline Industries, LP — Class II: Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54
Medline Industries, LP has initiated a Class II recall for four specific convenience kits due to the inclusion of a potentially contaminated component that was previously recalled by its original manufacturer.
Medline Industries, LP, healthcare facilities utilizing lithotomy and laparotomy convenience kits, and regulatory/quality professionals responsible for managing component-level recalls within finished device assemblies.
This recall highlights the downstream regulatory risks associated with convenience kits and finished device assemblies. When a sub-component is recalled by an upstream supplier for contamination, the kit assembler must manage the field action for all finished SKUs containing that component. The 'Ongoing' status suggests that inventory reconciliation and recovery efforts are still active.
Regulatory and QA teams should immediately identify and quarantine the specific Medline SKUs (DYNJ54362F, DYNJ900957C, DYNJ906804B, DYNJ910195A). Supply chain managers should verify whether the underlying component recall affects other custom or convenience kits in their inventory.
Class II. Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer. Product: Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
Open in openFDA / FDA.gov