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Recall Observatory FDA recall evidence

Device product

AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222

Z-0819-2025

November 26, 2024

Class II

Product summary

Firm
Applied Medical Technology Inc
Event
Event 95881
Status
Completed
Classification
Class II
Quantity
100
Official record key
device-enforcement:Z-0819-2025

Official wording

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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.