BEUDAMED
    FDA Enforcement Class II Terminated

    Synaptive Trackable Suction Set Standard and Malleable

    Recall: Z-1955-2021 · Reported July 7, 2021

    Enforcement

    Recall Number
    Z-1955-2021
    Event ID
    87937
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synaptive Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 7, 2021
    Initiation Date
    April 23, 2021
    Classification Date
    June 25, 2021
    Termination Date
    January 12, 2024
    Address
    555 Richmond St West, Suite 800, N/A, Toronto, N/A, N/A, Canada

    Description

    Synaptive Trackable Suction Set Standard and Malleable

    Reason

    Due to visible burrs/metal filings affixed along the suction tube inner perimeter.

    Code Info

    Set and components codes: SYN-0657, SYN-0783 Consumables 3 Packs SYN-0663, SYN-0664, SYN-0665, SYN-0666, SYN-0667, SYN-0668, SYN-0759, SYN-0760, SYN-0761, SYN-0762, SYN-0763, SYN-0764, SYN-0765 and SYN-0766. Consumables Singles SYN- 0651, SYN-0652, SYN-0653, SYN-0654, SYN-0655, SYN-0656, SYN-0671,SYN-0672, SYN-0673, SYN-0674, SYN-0675, SYN-0676, SYN-0677 and SYN-0778. All lots and all serial numbers.

    Distribution

    Domestic Distribution: IN, SC, MD, OR, TX ,LA, MI, NY, NV, FL, VA, CA,WI, PA and NC. International Distribution: Australia, Canada, Belgium, Netherlands, Singapore, Switzerland, Thailand, UK, Vietnam

    Quantity

    1291 units