BEUDAMED
    FDA Enforcement Class II Ongoing

    Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.

    Recall: Z-0227-2023 · Reported November 23, 2022

    Enforcement

    Recall Number
    Z-0227-2023
    Event ID
    90962
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    TELEFLEX LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2022
    Initiation Date
    September 20, 2022
    Classification Date
    November 11, 2022
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.

    Reason

    Product may not be sterile

    Code Info

    UDI (01)24026704323245(17)250405(10)74E2200810

    Distribution

    TN, CA, NC, TX, FL, OH, MO, IL, OR

    Quantity

    7200 catheters