BEUDAMED
    FDA Enforcement Class II Terminated

    Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile; A.4084/THE BEAK Diagnostic- Disposable proctoscope. Transparent. Sterile & Self lighting; A.4522/ MPR - Multi Purpose Rectoscope. 220mm long. Sterile & Disposable

    Recall: Z-1901-2021 · Reported June 30, 2021

    Enforcement

    Recall Number
    Z-1901-2021
    Event ID
    87812
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Adler MicroMed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 30, 2021
    Initiation Date
    April 23, 2021
    Classification Date
    June 21, 2021
    Termination Date
    October 4, 2022
    Address
    6842 Elaine Way, N/A, San Diego, CA, 92120-3933, United States

    Description

    Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile; A.4084/THE BEAK Diagnostic- Disposable proctoscope. Transparent. Sterile & Self lighting; A.4522/ MPR - Multi Purpose Rectoscope. 220mm long. Sterile & Disposable

    Reason

    Due to issue with product sterility. Sterilization service provider had falsified records.

    Code Info

    REF Numbers/Lot Numbers: REF A.4083 /Lot Numbers: 18D004l, 19C010l, 19l018l, 20l027l; REF A.4084/Lot Number: 19l015l; REF A.4519/Lot Numbers: 18l013l, 18l012l, 19D002l, 19F012l; REF A.4522/Lot Numbers: 18G003l, 19K023l; REF A.4086/Lot Number: 18F027l; Sterilization Batch Numbers: 18042311; 18092611; 18071211_1; 19040512; 18073112; 19092713; 19120612; 19063012; 20102212; 19063012;

    Distribution

    US distribution: FL, IL, MA, and PA.

    Quantity

    1,858 devices