Avanos Medical, Inc. — Class II: Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320
Avanos Medical, Inc. initiated a Class II recall for CORFLO Safety PEG Kits with ENFit Connectors (Model 50-5320) because they contained Lidocaine hydrochloride injection components that were subject to a supplier-level recall due to quality issues.
Affected parties include Avanos Medical, Inc., clinical personnel utilizing CORFLO PEG kits, and quality management professionals responsible for sterile convenience kit assembly and supplier oversight.
This recall highlights the downstream regulatory risk inherent in medical device kitting operations where a failure in a third-party pharmaceutical component necessitates a recall of the entire sterile device assembly. It suggests a potential vulnerability in supplier notification or material control processes when integrated components are recalled by their original manufacturer.
QA and Procurement teams should review existing kitting procedures to ensure that supplier-initiated recalls of individual components are monitored and triggers immediate internal containment workflows. Regulatory teams should assess whether other sterile kits utilize the same affected component from the third-party supplier.
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: 50-5320. Firm: Avanos Medical, Inc. (Alpharetta GA United States). Status: Ongoing.
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