AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6...
FDA Recall #Z-0819-2025 — Class II — November 26, 2024
Product Description
AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
Reason for Recall
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.
Recalling Firm
Applied Medical Technology Inc — Brecksville, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
100
Distribution
US Distribution to states of: CA, CT, FL, GA, IL, MA, MD, MO, NC, NJ, NY, OH, OK, PA, SC, TX, VA, WA
Code Information
Lot Code: Model No: E6-1222 UDI-DI: (01)00842071107086(17)270401(10)240424-628 Lot number: 240424-628 Exp. Date: 2027-04-01
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated