BEUDAMED
    FDA Enforcement Class II Terminated

    Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use less than 30 days.

    Recall: Z-2922-2020 · Reported September 9, 2020

    Enforcement

    Recall Number
    Z-2922-2020
    Event ID
    86200
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TELEFLEX MEDICAL INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2020
    Initiation Date
    August 7, 2020
    Classification Date
    August 28, 2020
    Termination Date
    January 14, 2023
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use less than 30 days.

    Reason

    Potential sterility issue

    Code Info

    74K1900074 74K1901335 74L1901435 74M1900809

    Distribution

    US Distribution of states to: AR AZ CA CO FL GA IA IL IN LA MI MN MS NC NH NV NY OH OK OR PA SD TN TX VA WA WI

    Quantity

    700 eaches