BEUDAMED
    FDA Recall Terminated

    AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- Type of packaging: 1 roll/pouch, 12 pouches/inner box, 4 inner box/case, 48 rolls per case. Conforming bandages used to cover and protect wounds from further injuries and contamination. This type of product fits all parts of the body without restrictive movement. To be used in health care facilities.

    Recall: Z-2213-2016 · Initiated March 30, 2016

    Recall

    Recall Number
    Z-2213-2016
    Event Number
    73696
    Firm
    Amd-Ritmed, Inc.
    FEI Number
    1319092
    Product Code
    FQM
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    March 30, 2016
    Terminated
    July 15, 2016
    Address
    295 Fire Tower Dr, Tonawanda, NY, 14150-5833

    Description

    AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- Type of packaging: 1 roll/pouch, 12 pouches/inner box, 4 inner box/case, 48 rolls per case. Conforming bandages used to cover and protect wounds from further injuries and contamination. This type of product fits all parts of the body without restrictive movement. To be used in health care facilities.

    Reason

    The product lot did not meet sterility requirements based on FDA sampling and analysis.

    Action

    The firm, AMD-Ritmed, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 3/30/2016 and Medical Device Recall Response Form to the US distributors/customers via e-mail. The letter described the product, problem and actions to be taken. The customers were instructed to examine your stock to determine if you have any; immediately discontinue distributing product; promptly return product via parcel post to Tonawanda/Buffalo warehouse, ATTENTION: RETURNED GOODS, AMD-Ritmed Inc., 295 Firetower Drive, Tonawanda, NY 14150; if you have further distributed the product, immediately contact your accounts, advise them of the recall situation and have them return their outstanding stock, and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE-Acknowledgment & Receipt Form via email to : [email protected] or fax to: 1-866-871-3455, ATTN: AMD-Ritmed Customer Service. If you have any questions, please contact us at (1-800-445-0340) or at AMD Customer Service [email protected].

    Distribution

    US Distribution in states of: NY, CA, and TN.

    Quantity

    US: 107 cases (48 rolls per case)