BEUDAMED
    FDA Recall Terminated

    McKesson Medi-Pak Elastic Bandages, Premium, Sterile; rolled elastic bandage, single patient use, knit, single self closure, latex-free; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in Canada, Packaged, sterilized and inspected in the U.S.A.; the elastic bandages are packaged in paper/poly pouches, 36 bandages per case in the following sizes: Product Number 16-1033-2-STR, 2' wide; 16-1033-3-STR, 3' wide; 16-1033-4-STR, 4' wide; and 16-1033-6-STR, 6' wide

    Recall: Z-0368-05 · Initiated December 2, 2004

    Recall

    Recall Number
    Z-0368-05
    Event Number
    30550
    Firm
    Cypress Medical Products, Ltd.
    FEI Number
    1451040
    Product Code
    FQM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 2, 2004
    Posted
    December 24, 2004
    Terminated
    September 21, 2005
    Address
    1202 S. Rte 31, McHenry, IL, 60050

    Description

    McKesson Medi-Pak Elastic Bandages, Premium, Sterile; rolled elastic bandage, single patient use, knit, single self closure, latex-free; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in Canada, Packaged, sterilized and inspected in the U.S.A.; the elastic bandages are packaged in paper/poly pouches, 36 bandages per case in the following sizes: Product Number 16-1033-2-STR, 2' wide; 16-1033-3-STR, 3' wide; 16-1033-4-STR, 4' wide; and 16-1033-6-STR, 6' wide

    Reason

    The elastic bandages which are labeled sterile have a lack of assurance of sterility.

    Action

    Cypress Medical recalled the elastic bandages fro McKesson Medical-Surgical on 12/1/04 by telephone call and letter. McKesson was requested to sub-recall the product from their customers, which they did by letter dated 12/2/04.

    Distribution

    Nationwide through McKesson Medical-Surgical warehouses in Kansas City, MO; Suwanee, GA; Baltimore, MD; Orlando, FL; Charlotte, NC; Nashville, TN; Richmond, VA; Atlanta, GA; Little Rock, AR; Grapevine, TX; Denver, CO; Tewksbury, MA; Cheshire, CT; Grove City, OH; Rochester, NY; Eagan, MN; Tempe, AZ; Auburn, WA; Livonia, MI; and Ontario, CA.

    Quantity

    17,964 units