AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
Summary
The FDA issued a Class II for AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/C by Applied Medical Technology Inc. Reason: The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit wit.
Details
Source
Device Recall
External ID
Z-0819-2025
Action Date
2025-01-15
Status
Completed
Category
device
Product Description
AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
Lot/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
Quantity Affected: 100
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-26
Company
Brecksville, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Applied Medical Technology Inc has 15 FDA actions in our database, including 11 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Applied Medical Technology Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Applied Medical Technology Inc have FDA actions?
Applied Medical Technology Inc has 15 FDA actions in our database, including 11 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0819-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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