BEUDAMED
    FDA Recall Terminated

    AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).

    Recall: Z-2045-2020 · Initiated December 17, 2019

    Recall

    Recall Number
    Z-2045-2020
    Event Number
    84739
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    JCW
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    December 17, 2019
    Posted
    January 28, 2020
    Terminated
    June 4, 2020
    Address
    300 Boston Scientific Way, Marlborough, MA, 01752-1291

    Description

    AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).

    Reason

    A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.

    Action

    On December 17, 2019, the firm sent an Urgent Medical Device Product Advisory letter to affected customers. Customers were informed of the labeling mix-up and instructed to add the advisory notice to the patient record. Customers were also asked to complete and returned an enclosed acknowledgement form. Customers with questions should contact their local Sales Representative.

    Distribution

    US Nationwide distribution including in the states of CA, MD, NC, NV, and TX.

    Quantity

    5