FDA Enforcement
Class II
Ongoing
Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No
Recall: Z-2340-2026
·
Reported June 17, 2026
Enforcement
- Recall Number
- Z-2340-2026
- Event ID
- 98907
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Avanos Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- June 17, 2026
- Initiation Date
- April 30, 2026
- Classification Date
- June 5, 2026
- Address
- 5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-4667, United States
Description
Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No
Reason
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Code Info
UDI-DI 10350770007530, Lot Numbers 30365233, 30367015, 30372821, 30378386
Distribution
US Nationwide distribution.
Quantity
54 kits