FDA Medical devices recall ·
AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port recall
- Recall number
- Z-0819-2025
- Date
- (initiated November 26, 2024)
- Company / brand
- Applied Medical Technology Inc
8006 Katherine Blvd, Brecksville, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 100
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Model No: E6-1222 UDI-DI: (01)00842071107086(17)270401(10)240424-628 Lot number: 240424-628 Exp. Date: 2027-04-01
Distribution
US Distribution to states of: CA, CT, FL, GA, IL, MA, MD, MO, NC, NJ, NY, OH, OK, PA, SC, TX, VA, WA
States: California Connecticut Florida Georgia Illinois Massachusetts Maryland Missouri North Carolina New Jersey New York Ohio Oklahoma Pennsylvania South Carolina Texas Virginia Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0819-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.