BEUDAMED
    FDA Recall Terminated

    Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 15 mm, 1550 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS175SB The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery.

    Recall: Z-1591-2011 · Initiated December 9, 2010

    Recall

    Recall Number
    Z-1591-2011
    Event Number
    57432
    Firm
    Anchor Products Company, Inc.
    FEI Number
    1416891
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 9, 2010
    Posted
    March 7, 2011
    Terminated
    January 20, 2012
    Address
    52 W Official Rd, Addison, IL, 60101-4519

    Description

    Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 15 mm, 1550 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS175SB The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery.

    Reason

    The metal component within the unit can break and cause a malfunction. Use of the device may represent a potential health hazard if the metal component is not removed after breakage.

    Action

    The firm, Anchor, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 8, 2010 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any remaining units to their distributor for replacement; and complete and return the attached ANCHOR RECALL RETURN RESPONSE FORM via fax to (314) 961-4535 or mail to: Progressive Medical, Inc., Attn: Marketing Manager, 11085 Gravois Industrial Court, St. Louis, MO 63128, even if they have no inventory. A representative of Anchor Products then visited each of the direct accounts to help them implement their subrecall of the devices from their customers. For additional information please contact: Vice President, Anchor Products Company at 1-800-543-9124 or 1-630-543-9124; and the distributor at 1-800-969-6331 or 1-314-961-4535.

    Distribution

    Worldwide distribution: USA including state of: Missouri; and countries including: Australia, Belgium, Canada, France, Greece, Ireland, Japan, Spain and the United Kingdom.

    Quantity

    2,256 units