BEUDAMED
    FDA Enforcement Class II Terminated

    AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.

    Recall: Z-3281-2018 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-3281-2018
    Event ID
    80652
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Neurovascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 10, 2018
    Initiation Date
    May 2, 2018
    Classification Date
    September 28, 2018
    Address
    47900 Bayside Pkwy, Fremont, CA, 94538-6515, United States

    Description

    AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.

    Reason

    The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.

    Code Info

    Lot No. 20156091 ;UPN: GEN-10800-80-S2 UDI (01)07613327298253 (17)201130 (10) 20156091.

    Distribution

    Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV.

    Quantity

    15 units