BEUDAMED
    FDA Recall Terminated

    SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,

    Recall: Z-3240-2017 · Initiated September 13, 2017

    Recall

    Recall Number
    Z-3240-2017
    Event Number
    78117
    Firm
    The Metrix Company
    FEI Number
    1000117446
    Product Code
    KPE
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    September 13, 2017
    Posted
    September 29, 2017
    Terminated
    May 25, 2018
    Address
    4400 Chavenelle Rd, Dubuque, IA, 52002-2655

    Description

    SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,

    Reason

    The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes.

    Action

    Recall letters will be sent to each consignee (distributors) via FedEx. The letter requested the following: "The Metrix Company is asking all customers to follow the steps below: 1. Recalled products must not be used. 2. Locate and quarantine all affected products. 3. Destroy all affected products and dispose/recycle in a manner consistent with your local waste disposal authority. 4. Complete the Response form and return it to The Metrix Company according to the instructions on the form." Distributors were instructed to contact their customers about the recall. The product is to be destroyed in the field.

    Distribution

    AZ, MA, IL, FL

    Quantity

    50 cases of 200 units