BEUDAMED
    FDA Enforcement Class II Terminated

    Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Stroke intervention kit

    Recall: Z-0275-2018 · Reported December 27, 2017

    Enforcement

    Recall Number
    Z-0275-2018
    Event ID
    78607
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Neurovascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 27, 2017
    Initiation Date
    November 3, 2017
    Classification Date
    December 21, 2017
    Termination Date
    November 4, 2019
    Address
    47900 Bayside Pkwy, Fremont, CA, 94538-6515, United States

    Description

    Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Stroke intervention kit

    Reason

    Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.

    Code Info

    Lot Numbers: QXC10200044, exp. date 28-Aug-18; QXC10200043, exp. date 28-Aug-18

    Distribution

    International Distribution to: Germany, Slovakia and Israel.

    Quantity

    2 units