BEUDAMED
    FDA Enforcement Class III Terminated

    RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.

    Recall: Z-1671-2013 · Reported July 17, 2013

    Enforcement

    Recall Number
    Z-1671-2013
    Event ID
    65347
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 17, 2013
    Initiation Date
    May 28, 2013
    Classification Date
    July 10, 2013
    Termination Date
    February 10, 2014
    Address
    100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States

    Description

    RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.

    Reason

    Product labeled with incorrect expiration date.

    Code Info

    Lot/Batch Number: 091541

    Distribution

    Worldwide Distribution - USA Nationwide including the state of NY, NE, MD, OH, TX, PA, VA, PR, CA, NJ, NY, CA and the countries of: AT, FR, DE, GB, IL, IT, LB, NL, ES, SE, TN, Argentina, and Japan.

    Quantity

    91