BEUDAMED
    FDA Recall 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 · Initiated April 23, 2021

    Recall

    Recall Number
    Z-1901-2021
    Event Number
    87812
    Firm
    Adler MicroMed, Inc.
    FEI Number
    3011412640
    Product Code
    KDM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 23, 2021
    Terminated
    October 4, 2022
    Address
    6842 Elaine Way, San Diego, CA, 92120-3933

    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.

    Action

    On 04/23/2021, the Recalling Firm communicated an URGENT: MEDICAL RECALL message via a telephone calls to customers and followed up email with a notification letter, informing them that the affected products that are labeled as sterile may not be sterile and the products could affect the sterile field and cause patient infections. Customers are instructed to: 1) Segregate and quarantine the affected products and wait for further instructions for disposition to follow, and 2) Complete and return the attached Acknowledgement and Receipt Form and indicate the quantities and location of the recalled products.

    Distribution

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

    Quantity

    1,858 devices