BEUDAMED
    FDA Enforcement Class II Terminated

    POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENF-50P-80 d) ENF-60P-40 e) ENF-60P-50 f) ENF-60P-80 g) ENF-80P-40 h) ENF-80P-50 i) ENF-80P-80 j) ENF-100P-110 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.

    Recall: Z-3073-2017 · Reported September 6, 2017

    Enforcement

    Recall Number
    Z-3073-2017
    Event ID
    77729
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kentec Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 6, 2017
    Initiation Date
    June 23, 2017
    Classification Date
    August 25, 2017
    Termination Date
    April 14, 2020
    Address
    17871 Fitch, N/A, Irvine, CA, 92614-6001, United States

    Description

    POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENF-50P-80 d) ENF-60P-40 e) ENF-60P-50 f) ENF-60P-80 g) ENF-80P-40 h) ENF-80P-50 i) ENF-80P-80 j) ENF-100P-110 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.

    Reason

    Inadequate detectability of radiopaque stripes

    Code Info

    a) ENF-50P-40, lot number KS1606031 b) ENF-50P-50, lot number KS1606028 c) ENF-50P-80, lot number KS1608007 d) ENF-60P-40, lot number KS1608008 e) ENF-60P-50, lot number KS1606029 f) ENF-60P-80, lot number KS1608009 g) ENF-80P-40, lot number KS1606032 h) ENF-80P-50, lot number KS1606030 i) ENF-80P-80, lot number KS1606034 j) ENF-100P-110, lot number KS1608010

    Distribution

    TX, VA, IL, CA, KS

    Quantity

    54 boxes of 10 individual units