BEUDAMED
    FDA Recall Terminated

    Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of the tube to facilitate the plug/ insertion of the device and also includes a male connector that can be used for devices designed with female connectors, This product is sterile, non-conductive and latex free.

    Recall: Z-0936-2018 · Initiated October 24, 2017

    Recall

    Recall Number
    Z-0936-2018
    Event Number
    79352
    Firm
    Medtronic Minimally Invasive Therapies Group
    FEI Number
    1282497
    Product Code
    GAZ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 24, 2017
    Posted
    March 5, 2018
    Terminated
    October 26, 2020
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    Description

    Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of the tube to facilitate the plug/ insertion of the device and also includes a male connector that can be used for devices designed with female connectors, This product is sterile, non-conductive and latex free.

    Reason

    Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as the Salem Sump Dual Lumen Stomach Tube. This product may have been distributed within the case of Argyle Suction Tubing.

    Action

    An URGENT MEDICAL DEVICE RECALL letter was issued to customers on October 24, 2017. This letter notified customers of the products subject to the recall and stated the following: The primary package labeling (Label closest to the product) may be incorrect. Customers can identify the affected product by consulting Attachment B. Please quarantine and return any unused products of the item codes and lot detailed above. Unused products from the affected item code and lots should be returned as described in the Required Actions section below. If you have distributed the Argyle" Suction tubing listed above, please promptly forward the information from this letter to those recipients. All unused products from the affected item codes and lots must be returned. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.

    Distribution

    USA (nationwide) Distribution

    Quantity

    58,954