BEUDAMED
    FDA Recall Terminated

    Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and underpad; 100 kits per box; Rusch, 2450 Meadowbrook Pwy, Duluth, GA 30096, Assembled in Mexico from U.S. Components; product number RLA-142-3

    Recall: Z-1083-05 · Initiated July 11, 2005

    Recall

    Recall Number
    Z-1083-05
    Event Number
    32627
    Firm
    Teleflex Medical
    FEI Number
    3004959265
    Product Code
    FCM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 11, 2005
    Posted
    August 4, 2005
    Terminated
    November 14, 2007
    Address
    2345 Waukegan Rd, Ste 120, Bannockburn, IL, 60015-1580

    Description

    Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and underpad; 100 kits per box; Rusch, 2450 Meadowbrook Pwy, Duluth, GA 30096, Assembled in Mexico from U.S. Components; product number RLA-142-3

    Reason

    There is a lack of assurance of sterility for parts of these lots of product.

    Action

    Teleflex Medical sent their customers recall letters dated July 11, 2005 via UPS, 2 Day Delivery, on July 13, 2005. The customers were informed that there were documentation discrepancies for the two lots which impact the level of assurance that all of the units are sterile, and were instructed to remove and quarantine all affected product immediately and return the product to Teleflex Medical at Research Triangle Park, NC. Any questions were directed to Dan Daily at 1-800-334-9751, ext. 4029. The recall was extended to include the two additional lots by letter dated 11/15/05. The customers were informed that there were documentation discrepancies for the two lots which impact the level of assurance that all of the units are sterile, and were instructed to remove and quarantine all affected product immediately and return the product to Teleflex Medical at Durham, NC. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

    Distribution

    Nationwide

    Quantity

    95,800 units