BEUDAMED
    FDA Recall Terminated

    POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c) ENF-Y60P-40 d) ENF-Y60P-50 e) ENF-Y60P-90 f) ENF-Y80P-40 g) ENF-Y80P-50 h) ENF-Y80P-80 i) ENF-Y80P-90 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.

    Recall: Z-3074-2017 · Initiated June 23, 2017

    Recall

    Recall Number
    Z-3074-2017
    Event Number
    77729
    Firm
    Kentec Medical Inc
    FEI Number
    2080225
    Product Code
    FPD
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 23, 2017
    Posted
    July 22, 2017
    Terminated
    April 14, 2020
    Address
    17871 Fitch, Irvine, CA, 92614-6001

    Description

    POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c) ENF-Y60P-40 d) ENF-Y60P-50 e) ENF-Y60P-90 f) ENF-Y80P-40 g) ENF-Y80P-50 h) ENF-Y80P-80 i) ENF-Y80P-90 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

    Action

    The firm notified their consignees by telephone and email on 06/23/2017, and followed with a letter sent certified mail, on 07/07/2017. The letter instructed the consignee to cease use of the product, isolate it, and contact Kentec.

    Distribution

    TX, VA, IL, CA, KS

    Quantity

    K100526