BEUDAMED
    FDA Recall Terminated

    Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. Distributed by Medtronic, Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA.

    Recall: Z-1159-06 · Initiated April 6, 2006

    Recall

    Recall Number
    Z-1159-06
    Event Number
    35094
    Firm
    Medtronic Gastroenterology Urology
    FEI Number
    1000135098
    Product Code
    KLA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 6, 2006
    Posted
    June 22, 2006
    Terminated
    January 16, 2007
    Address
    4000 Lexington Ave N, Shoreview, MN, 55126-2917

    Description

    Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. Distributed by Medtronic, Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA.

    Reason

    Mislabeling- The 8 ports of the manometric catheter were incorrectly labeled 1,3,5,7,8,2,4,6 from the distal to the proximal end of the catheter. The correct port configuration is sequentially 1 through 8, from the distal to the proximal end of the catheter.

    Action

    Recall initiated to International accounts on 04/05/06 and within US on 04/06/06 via an Urgent Recall Notification. The letter informs them of the manufacturing defect, requests return for credit of any unused inventory and requests accounting of all previously used catheters. Distributors are instructed to sent a letter to their customers to request product return.

    Distribution

    Worldwide Distribution-including states of IL, NC, NY. and countries of Austria, Chile, Finland, Germany, Greece, Hong Kong, Italy, Japan, Lebanon, Norway, Peru, Portugal, Saudi Arabi, Spain

    Quantity

    94 catheters (US - 4; OUS - 90)