BEUDAMED
    FDA Recall Terminated

    Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring tube, an insufflation tube, an irrigation tube, a suction tube, a pump tube, and a connection tube; a sterile, disposable, single use accessory to the TEM (Transanal Endoscopic Microsurgery) System used for insufflation of the rectal cavity; Manufacturer: Richard Wolf GmbH, Postfoch 1164, D-75343 Knittlingen, Deutschland; Product Number 4170.801

    Recall: Z-1430-06 · Initiated July 7, 2006

    Recall

    Recall Number
    Z-1430-06
    Event Number
    35845
    Firm
    Richard Wolf Medical Instruments Corp.
    FEI Number
    1418479
    Product Code
    HIF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 7, 2006
    Posted
    August 24, 2006
    Terminated
    June 15, 2007
    Address
    353 Corporate Woods Pkwy, Vernon Hills, IL, 60061-3110

    Description

    Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring tube, an insufflation tube, an irrigation tube, a suction tube, a pump tube, and a connection tube; a sterile, disposable, single use accessory to the TEM (Transanal Endoscopic Microsurgery) System used for insufflation of the rectal cavity; Manufacturer: Richard Wolf GmbH, Postfoch 1164, D-75343 Knittlingen, Deutschland; Product Number 4170.801

    Reason

    The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed.

    Action

    Richard Wolf field sales representatives telephoned the end users on 7/7/06, informing them that the blue connectors on the irrigation tube may be reversed in the tube set bundle for lot 060232 only. The end users were requested to return the affected lot of tubes for replacement at no charge, contacting Ms. Ellen Huffman at 800-323-9653, ext. 280 to make arrangements for the exchange of product. Any questions concerning the recall were directed to Ms. Huffman or Robert Casarsa at the same number.

    Distribution

    Nationwide distribution --- including the states of Alabama, Florida, District of Columbia, Michigan, Minnesota, Nebraska, New York, Ohio, Oregon, Pennsylvania, Utah, Vermont and Wisconsin.

    Quantity

    100 sets