BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2095-2023 · Initiated May 25, 2023

    Recall

    Recall Number
    Z-2095-2023
    Event Number
    92416
    Firm
    TELEFLEX LLC
    FEI Number
    3005747797
    Product Code
    KAL
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    May 25, 2023
    Posted
    July 5, 2023
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    Description

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

    Reason

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

    Action

    Teleflex issued an URGENT MEDICAL DEVICE NOTIFICATION to its consignees on 05/25/2023 by Fed Ex 2nd day delivery. The notice explained the problem, the risk to health, and requested the following actions be taken: Medical facilities are to check the facilities for the product and place a copy of the notice with it. Distributors are directed to check for the product and place a copy of the notice with the product, and notify all customers to whom the product has been distributed.

    Distribution

    Nationwide and Australia, Canada, S. Korea, Singapore

    Quantity

    365 units