BEUDAMED
    FDA Recall Terminated

    Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408

    Recall: Z1855-2015 · Initiated April 23, 2015

    Recall

    Recall Number
    Z1855-2015
    Event Number
    70985
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    NYU
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 23, 2015
    Posted
    July 1, 2015
    Terminated
    July 26, 2017
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408

    Reason

    Catheters may not meet antimicrobial specification

    Action

    Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878. For questions regarding this recall call 203-492-5000.

    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