BEUDAMED
    FDA Recall Terminated

    TFE Coated Curved Newton LLT

    Recall: Z-0963-2018 · Initiated October 13, 2017

    Recall

    Recall Number
    Z-0963-2018
    Event Number
    79195
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    October 13, 2017
    Terminated
    October 23, 2019
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    TFE Coated Curved Newton LLT

    Reason

    Label does not state that the product is heparin-coated.

    Action

    On October 31, 2017 an URGENT MEDICAL DEVICE CORRECTION was issued to customers requesting the following, including a corrective action: Step 1: Determine if your product is included in the affected lot ranges by comparing your lot number to the listing provided. " If your product is not affected, complete the Acknowledgement and Receipt Form. " If your product is affected, proceed to Step 2. Step 2: Remove a Heparin Coated label from the label sheet provided and apply to the top right corner of your affected unit. o If you need additional labels, please contact Stericycle at 855.215.4967. If you would like assistance, representatives are available to support you. To request assistance, please contact Stericycle at 855.215.4967

    Distribution

    Nationally

    Quantity

    3,364