FDA Enforcement
Class II
Ongoing
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
Recall: Z-2348-2026
·
Reported June 17, 2026
Enforcement
- Recall Number
- Z-2348-2026
- 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: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
Reason
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Code Info
UDI-DI 10350770007820, Lot Numbers 30371324, 30374833, 30384889, 80403350
Distribution
US Nationwide distribution.
Quantity
1,615 kits