BEUDAMED
    FDA Enforcement Class II Ongoing

    Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor

    Recall: Z-2095-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2095-2023
    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 O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor

    Reason

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

    Code Info

    Lot Numbers: B5, B6, B9, C6, C7, D2, D6, E5, E9, F2, F3, F5, F8, G4, G5, G9, I3, I4, I7, I8, J2, J3, K4, K5, K7, K8, L2, L9, O2, Q0, R2, S2, U0, V2, W1

    Distribution

    Nationwide and Australia, Canada, S. Korea, Singapore

    Quantity

    365 units