FDA Enforcement
Class II
Ongoing
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24
Recall: Z-2349-2026
·
Reported June 17, 2026
Enforcement
- Recall Number
- Z-2349-2026
- 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 24 Fr PUSH OTW Model/Catalog Number: 8170-24
Reason
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Code Info
UDI-DI 10350770007837, Lot Numbers 30371847, 30374834, 30378748, 30380347
Distribution
US Nationwide distribution.
Quantity
234 kits