BEUDAMED
    FDA Recall Terminated

    Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly, product code: 340-4176, Method of Sterilization using Ethylene Oxide. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

    Recall: Z-1672-2012 · Initiated May 18, 2012

    Recall

    Recall Number
    Z-1672-2012
    Event Number
    61895
    Firm
    MOOG Medical Devices Group
    FEI Number
    1000117172
    Product Code
    FPK
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    May 18, 2012
    Posted
    May 30, 2012
    Terminated
    February 22, 2013
    Address
    4314 Zevex Park Ln, Salt Lake City, UT, 84123-7881

    Description

    Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly, product code: 340-4176, Method of Sterilization using Ethylene Oxide. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

    Reason

    Moog Medical Device Group became aware on March 23, 2011 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.

    Action

    The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: [email protected].

    Distribution

    Nationwide distribution: USA including states of: AZ, CA, FL, IL, KS, MA, MI, MD, NC, ND, NY, OK, OH, and TX.

    Quantity

    4,080 sets.