BEUDAMED
    FDA Recall Terminated

    Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel: 4.2 MM * Disposable Single Use Only * Compatible Wire Guide: .035'' * Rx Only * Wilson-Cook Medical * GI Endoscope * 4900 Betharine Station * Winston-Salem, NC 27105

    Recall: Z-0270-06 · Initiated October 31, 2005

    Recall

    Recall Number
    Z-0270-06
    Event Number
    33945
    Firm
    Wilson-Cook Medical Inc
    FEI Number
    1037905
    Product Code
    FGY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 31, 2005
    Posted
    December 7, 2005
    Terminated
    June 7, 2007
    Address
    5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206

    Description

    Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel: 4.2 MM * Disposable Single Use Only * Compatible Wire Guide: .035'' * Rx Only * Wilson-Cook Medical * GI Endoscope * 4900 Betharine Station * Winston-Salem, NC 27105

    Reason

    Misbranded; The catheter size listed on the product label is 6 French, which is inaccurate. The catheter size is more accurately described as 7 French.

    Action

    Consignees were notified by letter on/about 11/04/2005.

    Distribution

    Nationwide, Argentina, Australia, Bahamas, Bolivia, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Denmark, Ecuador, Egypt, El Salvador, Guatemala, Holland, Hong Kong, India, Ireland, Israel, Korea, Malaysia, New Zealand, Peru, Puerto Rico, Singapore, Taiwan, Uruguay, Venezuela, and West Indies.

    Quantity

    1045 units