FDA recall Z-0819-2025

Applied Medical Technology Inc · Class II · device

Product

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.

Distribution

US Distribution to states of: CA, CT, FL, GA, IL, MA, MD, MO, NC, NJ, NY, OH, OK, PA, SC, TX, VA, WA

Key facts

Status: Completed
Initiation date: 2024-11-26
Report date: 2025-01-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brecksville, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0819-2025