BEUDAMED
    FDA Recall Terminated

    100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm). Reorder No. 3607. Manufactured for dynarex Corporation, Orangeburg, NY 10962. Sterile with non-stick pad. 100% Latex Free Bandage & Wrapper. 48 boxes of 100 bandages per case. --- Device Listing # E177598. 510(k) Exempt.

    Recall: Z-0951-04 · Initiated May 10, 2004

    Recall

    Recall Number
    Z-0951-04
    Event Number
    29031
    Firm
    Dynarex Corporation
    FEI Number
    2431014
    Product Code
    FQM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 10, 2004
    Posted
    July 20, 2004
    Terminated
    August 30, 2012
    Address
    10 Glenshaw Street, Orangeburg, NY, 10962-1207

    Description

    100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm). Reorder No. 3607. Manufactured for dynarex Corporation, Orangeburg, NY 10962. Sterile with non-stick pad. 100% Latex Free Bandage & Wrapper. 48 boxes of 100 bandages per case. --- Device Listing # E177598. 510(k) Exempt.

    Reason

    Bandages labeled as "100% Latex Free" may contain latex. The wrapper was analytically tested by a private laboratory and found to contain latex.

    Action

    Recall letters & response forms were sent to the consignees on 5/10/04 via Certified Mail, Return Receipt Requested. On 5/24/04, a second recall letter & response form were mailed via Certified Mail to the 60 distributors that received the 2 additional lots being recalled.

    Distribution

    Medical supply distributors located in NY, NJ, PA, TX, MN, GA, FL, MI, OH, IL, MS, KY, AZ , CA, NV, CO, and Puerto Rico, for further distribution to their customers. --- UPDATE: There were 2 foreign accounts in Panama that received the additional lots. The additional lots were distributed to the aforementioned states plus the following states: MA, MO, ME, VA, NC, LA.

    Quantity

    50 cases (Lot 15860); 166 cases (lots 15901, 15706)