FDA Enforcement
Class II
Completed
AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
Recall: Z-0819-2025
·
Reported January 15, 2025
Enforcement
- Recall Number
- Z-0819-2025
- Event ID
- 95881
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Applied Medical Technology Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 15, 2025
- Initiation Date
- November 26, 2024
- Classification Date
- January 7, 2025
- Address
- 8006 Katherine Blvd, Brecksville, OH, 44141-4202, United States
Description
AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
Reason
The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors.
Code Info
Lot Code: Model No: E6-1222 UDI-DI: (01)00842071107086(17)270401(10)240424-628 Lot number: 240424-628 Exp. Date: 2027-04-01
Distribution
US Distribution to states of: CA, CT, FL, GA, IL, MA, MD, MO, NC, NJ, NY, OH, OK, PA, SC, TX, VA, WA
Quantity
100