BEUDAMED
    FDA Enforcement Class II Ongoing

    Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor

    Recall: Z-2097-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2097-2023
    Event ID
    92416
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    TELEFLEX LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 12, 2023
    Initiation Date
    May 25, 2023
    Classification Date
    July 5, 2023
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor

    Reason

    There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

    Code Info

    Lot Numbers: A6, A7, A8, C3, C8, E6, G9, I8, I9, Q0, S2, W1,

    Distribution

    Nationwide and Australia, Canada, S. Korea, Singapore

    Quantity

    32 units