BEUDAMED
    FDA Recall 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 · Initiated May 2, 2018

    Recall

    Recall Number
    Z-3281-2018
    Event Number
    80652
    Firm
    Stryker Neurovascular
    FEI Number
    3008853977
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 2, 2018
    Address
    47900 Bayside Pkwy, Fremont, CA, 94538-6515

    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.

    Action

    On 5/2/2018, "Urgent Medical Device Customer Communication" notifications were mailed via courier. Customers were informed to complete and return a Customer Acknowledgement Form. Customers with questions are encouraged to call (510) 413-2100.

    Distribution

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

    Quantity

    15 units