BEUDAMED
    FDA Recall Terminated

    MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040

    Recall: Z-0494-2020 · Initiated October 11, 2019

    Recall

    Recall Number
    Z-0494-2020
    Event Number
    84118
    Firm
    AMD Medicom Inc.
    FEI Number
    3002677549
    Product Code
    FXX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 11, 2019
    Terminated
    September 14, 2021
    Address
    1200 55e Ave, Lachine Canada

    Description

    MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040

    Reason

    Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended.

    Action

    Urgent Medical Device Recall notification letters dated 10/11/19 were sent to customers. AMD Medicom requests that you discontinue distribution/use of and return all products from the catalog/lot number referenced above, for a credit. Our records indicate that you have purchased one or more of product code 2040 for re-sale to your customers. You should complete the attached Acknowledgment Form for inventory you have received and/or which is still in stock. AMD Medicom requests that you complete and return the Acknowledgment Form enclosed with this letter, even if you do not have the above-mentioned lot numbers in your inventory, within three (3) working days. In addition, please contact your affected customer base, advise them of the recall and provide them with a copy of this letter. You should insert your contact information, email and fax numbers in the Acknowledgement Form and request that they return the Acknowledgment Form to you. Please have them return any unused inventory to you for reconciliation. Once you have received all inventory from your customers, please contact Medicom customer service at 1-800-308-6589 or [email protected] to receive a Sales Return Order number to identify your shipment of returns. Please return all units of the affected lots (unsold inventory and returns) to: AMO Medicom Inc. 6054 Shook Road, Suite 200 Lockbourne, OH USA 43137 ATTN: Recall You may use the following courier information: UPS Account# V28W12

    Distribution

    The products were distributed tot he following US states: CA, FL, IA, IN, MD, MI, NV, NY, PA, SC, TN, TX, and WA. The products were distributed to the following foreign countries: Canada.

    Quantity

    756 cases (500 units/case)