BEUDAMED
    FDA Recall Open, Classified

    PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is composed of Phthalate-free PVC material and is available in straight, right angle, and trocar configurations in a variety of sizes. The catheter is soft enough to prevent tissue laceration during insertion and tissue pressure necrosis due to the catheter being left in place for a period of time. The catheter is also rigid enough to facilitate insertion of the tube and to avoid obstruction by external compression or kinking.

    Recall: Z-1298-2021 · Initiated February 12, 2021

    Recall

    Recall Number
    Z-1298-2021
    Event Number
    87346
    Firm
    TELEFLEX MEDICAL INC
    FEI Number
    3005747797
    Product Code
    GBX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 12, 2021
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    Description

    PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is composed of Phthalate-free PVC material and is available in straight, right angle, and trocar configurations in a variety of sizes. The catheter is soft enough to prevent tissue laceration during insertion and tissue pressure necrosis due to the catheter being left in place for a period of time. The catheter is also rigid enough to facilitate insertion of the tube and to avoid obstruction by external compression or kinking.

    Reason

    Teleflex is recalling this product due to a lack of assurance of sterility.

    Action

    The affected customer is instructed to take the following actions: 1. If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products.

    Distribution

    US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.

    Quantity

    520 units (US only)