BEUDAMED
    FDA Recall Terminated

    Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention kit

    Recall: Z-0277-2018 · Initiated November 3, 2017

    Recall

    Recall Number
    Z-0277-2018
    Event Number
    78607
    Firm
    Stryker Neurovascular
    FEI Number
    3008853977
    Product Code
    NRY
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    November 3, 2017
    Posted
    December 5, 2017
    Terminated
    November 4, 2019
    Address
    47900 Bayside Pkwy, Fremont, CA, 94538-6515

    Description

    Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 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.

    Action

    The firm, Stryker Neurovascular, sent an "Urgent Medical Device Voluntary Recall Immediate Action Required" letter initiating their recall on 11/01/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately check internal inventory; remove and discard the procedure pack carton sleeve; circulate notice; maintain awareness of notice internally until all required actions have been completed with your facility; inform Stryker of any subject devices distributed to other organization, and complete and return customer response form to your nominated Stryker Representative or to [email protected]. If you have any questions, call 510-413-2593; email: [email protected] or 510-413-2900.

    Distribution

    International Distribution to: Germany, Slovakia and Israel.

    Quantity

    1 unit