Avanos Medical, Inc. — Class II: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Mod
Avanos Medical, Inc. has initiated a Class II recall for its MIC Safety Percutaneous Endoscopic Gastrostomy (PEG) Kit after a supplier-level quality issue led to the recall of Lidocaine hydrochloride injection components included within the sterile kits.
This recall affects Avanos Medical, Inc., clinical personnel utilizing 24 Fr PUSH OTW feeding tube kits, and medical device manufacturers who assemble sterile procedure kits containing third-party pharmaceutical components.
The recall highlights the regulatory risks associated with kit assembly, where the compliance status of a finished medical device is dependent on the quality control of third-party pharmaceutical suppliers. While the issue originates with a supplier, the primary kit manufacturer remains responsible for managing the downstream impact and mitigation of the affected sterile sets. This underscores the necessity of robust supplier quality agreements and effective change control processes when integrating drugs into device kits.
QA and Procurement teams should review current supplier monitoring programs to ensure that third-party pharmaceutical recalls are promptly identified and matched against internal kit inventories. Regulatory teams should verify that finished good labels and kit configurations remain in compliance following the removal or replacement of internal components.
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: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No. Firm: Avanos Medical, Inc. (Alpharetta GA United States). Status: Ongoing.
Open in openFDA / FDA.gov