AMT Mini Enteral Extension Set Recalled for Incorrect Connector Type
Applied Medical Technology is recalling AMT Mini Enteral Extension Sets due to incorrect ENFit connector type. Affected units have ENFit connections instead of non-ENFit, preventing proper compatibility with intended systems.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a connector type mismatch that prevents proper device functionality. Although no injuries or illnesses are reported, the defect creates a risk of harm through improper use or connection failures, fitting the High severity category.
Plain-English summary
Applied Medical Technology Inc. is recalling AMT Mini Enteral Extension Sets, model E6-1222, 12-inch right-angle feeding sets with Y-port. According to the recall notice, these extension sets have ENFit connections, although they should have non-ENFit connections.
ENFit connectors only fit with other ENFit-compatible devices and will not fit with non-ENFit connectors. This connector type mismatch affects the intended use and compatibility of the device.
The recall involves 100 units with lot number 240424-628 and expiration date April 1, 2027. The affected units were distributed to the following U.S. states: California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, and Washington.
Users of these extension sets should verify their product lot numbers against the recalled lot and take appropriate action regarding the affected units.
The recalled product
- Product
- AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
- Manufacturer
- Applied Medical Technology Inc
- Category
- Medical Device — Enteral Feeding
- Affected units
- 100
Distribution
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