BEUDAMED
    FDA Enforcement Class II Terminated

    Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978

    Recall: Z-0106-2022 · Reported October 20, 2021

    Enforcement

    Recall Number
    Z-0106-2022
    Event ID
    88524
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 20, 2021
    Initiation Date
    August 6, 2021
    Classification Date
    October 13, 2021
    Termination Date
    May 17, 2024
    Address
    1266 Kifer Rd Bldg 101, N/A, Sunnyvale, CA, 94086-5304, United States

    Description

    Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978

    Reason

    Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.

    Code Info

    Affected Lot Number(s): S90200303, S90200622, S90200727, S90200811, S90200820, S90200831 ,S90200909, S90201008, S90201015 ,S90201103, S90201107, S90201125 ,S90201202, S90201204, S90210114 ,S90210211, S90210225, S90210310 ,S90210318, S90210408, S90210414

    Distribution

    US: AZ, AR, CA, CO, DC, FL, GA, IL, IN, IO, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, PA, TN, TX, UT, VA, WA OUS: China

    Quantity

    1625 units