Avanos Medical, Inc. — Class II: Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
Avanos Medical, Inc. has initiated a Class II recall for its CORFLO Safety PEG Kit with ENFit Connector (Model 50-4320) due to the inclusion of Lidocaine hydrochloride injection units that were subject to a supplier-level recall for quality issues.
This recall affects Avanos Medical, Inc., stakeholders managing the CORFLO Safety PEG Kit supply chain, and clinical facilities utilizing these specific sterile kits.
The recall highlights the regulatory risks associated with convenience kits where a single defective component—in this case, an outsourced drug component—compromises the entire sterile set. This suggests a need for robust supplier monitoring systems to ensure that upstream recalls of constituent parts are integrated into the final manufacturer's post-market safety actions.
Review incoming component quality agreements and supplier change notifications to ensure external drug recalls are promptly identified. Conduct a reconciliation of inventory for kits containing the specified Lidocaine hydrochloride injection to facilitate quarantine and removal as required.
Class II. Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.. Product: Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320. Firm: Avanos Medical, Inc. (Alpharetta GA United States). Status: Ongoing.
Open in openFDA / FDA.gov