BEUDAMED
    FDA Enforcement Class II Terminated

    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C

    Recall: Z-1863-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1863-2015
    Event ID
    70985
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2015
    Initiation Date
    April 23, 2015
    Classification Date
    June 30, 2015
    Termination Date
    July 26, 2017
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908, United States

    Description

    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C

    Reason

    Catheters may not meet antimicrobial specification

    Code Info

    Item codes identified with an expiry date of February 2018 and earlier

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

    Quantity

    72,363 US - 24,631 Internationally