Recall Z-0819-2025— Applied Medical Technology Inc

Name: FDA recall Z-0819-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-26

Class II · Ongoing

Class II FDA medical device recall by Applied Medical Technology Inc, initiated 2024-11-26. It names one FDA 510(k) clearance: K142989. Product: 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..

Recalling firm: Applied Medical Technology Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-11-26
Firm location: Brecksville, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K142989 — Mini ONE Enteral Extension SetApplied Medical Technology, Inc.·cleared 2015-01-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.