Cardinal Health 200, LLC — Class II: Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30S
Cardinal Health 200, LLC has initiated a Class II recall for specific Presource Harmonized Spine VCH PHC Packs (Catalog Number: SOP30SPBCC). The recall is due to the inclusion of MEDICOM Ritmed Neurological Sponges which were previously recalled for unexpected variability in endotoxin levels.
This recall affects Cardinal Health 200, LLC and healthcare facilities utilizing these specific spine procedure kits. It involves personnel in supply chain, surgical services, and quality compliance monitoring endotoxin specifications.
This action highlights the regulatory risk inherent in procedure kits where a sub-component recall necessitates a recall of the finished convenience kit. The presence of variable endotoxin levels in neurological sponges poses a clinical risk, and the ongoing status indicates that reconciliation of affected units is still in progress. For manufacturers, this underscores the importance of robust supplier quality monitoring and rapid downstream communication when a component manufacturer issues a recall.
Regulatory and supply chain teams should immediately identify if the specific catalog number (SOP30SPBCC) is in inventory. Quality units should review supplier management files for MEDICOM Ritmed and assess if other procedure kits utilize these neurological sponges. Clinical teams should be notified to sequester affected packs to prevent surgical use until the recall process is finalized.
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) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC. Firm: Cardinal Health 200, LLC (Waukegan IL United States). Status: Ongoing.
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