BEUDAMED
    FDA Recall Terminated

    Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufactured By: LeMaitre Vascular, Inc. 3101 37th Avenue North St. Petersburg, FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***''.

    Recall: Z-0219-06 · Initiated May 17, 2005

    Recall

    Recall Number
    Z-0219-06
    Event Number
    32971
    Firm
    LeMaitre Vascular, Inc.
    FEI Number
    1220948
    Product Code
    DQT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 17, 2005
    Posted
    November 30, 2005
    Terminated
    July 6, 2012
    Address
    3101 37th Ave N, St Petersburg, FL, 33713-1509

    Description

    Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufactured By: LeMaitre Vascular, Inc. 3101 37th Avenue North St. Petersburg, FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***''.

    Reason

    LeMaitre Vascular is recalling certain lots of its Pruitt Aortic Occlusion Catheters due to a packaging defect which could compromise product sterility.

    Action

    The distributors in Europe and Japan have been notified to contact their customers to return the products. All customers have been notified by letter.

    Distribution

    There are two lots in distribution (175 pieces) that may contain the small hole in the tray. These two lots were distributed in Japan and Europe. There are 16 lots in distribution (1,744 pieces) that utilize the trays with the thin spots that can potentially crack. These 16 lots were distributed in the United States, Canada, Japan and the European Union.

    Quantity

    1,919