BEUDAMED
    FDA Enforcement Class II Terminated

    SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult

    Recall: Z-1366-2021 · Reported April 14, 2021

    Enforcement

    Recall Number
    Z-1366-2021
    Event ID
    87432
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sharp Medical Products
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 14, 2021
    Initiation Date
    February 8, 2021
    Classification Date
    April 6, 2021
    Termination Date
    February 17, 2023
    Address
    14362 N Frank Lloyd Wright Blvd, N/A, Scottsdale, AZ, 85260-8846, United States

    Description

    SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult

    Reason

    Non-conformity (holes/punctures or deep creases) in the sterile barrier.

    Code Info

    Catalogue Number: 100-36-01 Lot Number: 0818-009

    Distribution

    U.S.: AZ, FL, MI, OH, TX, and WI. O.U.S.: None

    Quantity

    129 units (63 units for Human-use and 66 units for Non-Human use)