BEUDAMED
    FDA Recall Terminated

    Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.

    Recall: Z-0329-2016 · Initiated October 14, 2015

    Recall

    Recall Number
    Z-0329-2016
    Event Number
    72416
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    NYU
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 14, 2015
    Posted
    November 24, 2015
    Terminated
    June 2, 2017
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.

    Reason

    Incorrectly packaged with a 90 degree bend at the distal tip

    Action

    The firm, Medtronic (Covidien), sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/16/2015 to their customers. The letter described the product, problem, and actions to be taken. Customers were instructed to quarantine and discontinue use of the product, return affected product and complete and return the RECALLED PRODUCT RETURN FORM via Fax to Medtronic to (800)-895-6140 or email to: [email protected]/Distributor to (203) 492-7719 or email to: [email protected]. Questions or concerns contact your Medtronic representative or Customer Service at (800) 882-5878.

    Distribution

    Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom.

    Quantity

    280 units