BEUDAMED
    FDA Recall Terminated

    Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 461438. Intended for pediatric feeding.

    Recall: Z-1033-2016 · Initiated January 21, 2016

    Recall

    Recall Number
    Z-1033-2016
    Event Number
    73115
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    January 21, 2016
    Posted
    March 2, 2016
    Terminated
    June 1, 2017
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 461438. 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

    Action

    Medtronic/Covidien Customers notified via an Urgent Medical Device Recall letter, dated January 22, 2016. The letter identifies the affected product, instructs customers to discontinue use and quarantine any of the product, and return all affected inventory. Customers are also to complete the "Recalled Product Return Form." Questions or concerns can be directed to a Medtronic representative or Customer Service at 800-882-5878.

    Distribution

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

    Quantity

    1,010 units