Cardinal Health 200, LLC — Class II: Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726
Cardinal Health 200, LLC has initiated a Class II recall for various Presource Kits, including ENT, Sinus, and Head and Neck trays. The action was prompted by the inclusion of MEDICOM Ritmed Neurological Sponges within the kits that were recalled due to unexpected variability in endotoxin levels.
This recall affects Cardinal Health 200, LLC, clinical facilities utilizing specialized ENT and neurological procedure kits, and quality management professionals responsible for sterile kit components and supplier oversight.
This event highlights the regulatory risks associated with convenience kits where a sub-component failure triggers a recall of the higher-level assembly. Variability in endotoxin levels suggests potential lapses in sterility assurance or raw material controls by the sub-tier manufacturer, which may necessitate a review of supplier qualification and incoming material inspection protocols for kit assemblers.
QA and supply chain teams should immediately identify if any Cardinal Health Presource Kits with the specified catalog numbers are in inventory. Affected units should be quarantined according to internal recall procedures, and procurement teams should verify the status of neurological sponges sourced from sub-tier suppliers.
Class II. Reason: Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.. Product: Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog Number: PE33HNCR2; 9) KIT, HEAD AND NECK , Catalog Number: PE33HNCR3; 10) KIT, HEAD AND NECK , Catalog Number: PE33HNCR4; 11) KIT, HEAD AND NECK , Catalog Number: PE33HNCRA; 12) KIT, HEAD AND NECK , Catalog Number: PE33HNCRB; 13) KIT, NASAL , Catalog Number: PE35NSB23; 14) KIT, NASAL , Catalog Number: PE35NSBLG; 15) KIT, EENT , Catalog Number: PE44EMKW8;. Firm: Cardinal Health 200, LLC (Waukegan IL United States). Status: Ongoing.
Open in openFDA / FDA.gov