BEUDAMED
    FDA Enforcement Class II Terminated

    Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701. Intended for pediatric feeding.

    Recall: Z-1034-2016 · Reported March 9, 2016

    Enforcement

    Recall Number
    Z-1034-2016
    Event ID
    73115
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2016
    Initiation Date
    January 21, 2016
    Classification Date
    March 2, 2016
    Termination Date
    June 1, 2017
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701. Intended for pediatric feeding.

    Reason

    8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs

    Code Info

    Lot Code: 521808064X

    Distribution

    Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.

    Quantity

    1,330 units