BEUDAMED
    FDA Recall Open, Classified

    Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only

    Recall: Z-2268-2024 · Initiated May 10, 2024

    Recall

    Recall Number
    Z-2268-2024
    Event Number
    94726
    Firm
    Stryker Sustainability Solutions
    FEI Number
    3002615969
    Product Code
    NLH
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 10, 2024
    Posted
    July 3, 2024
    Address
    10232 S 51st St, Phoenix, AZ, 85044-5205

    Description

    Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only

    Reason

    Diagnostic electrophysiology (EP) catheters do not meet testing requirements.

    Action

    On June 11, 2024, Stryker Sustainability Solutions issued a Medical Device Recall notification to affected consignees. Stryker ask consignees to take the following action: 1. Please complete the Urgent Medical Device Recall Business Reply Form Attachment A (page 3) as an acknowledgement of this notification. Please return this completed form through one of the following methods: "Email: [email protected] or To your Stryker s Sustainability Solutions Sales Representative or via: Fax: 480-763-5345 5. 2.Maintain awareness of this communication internally. Response is required.

    Distribution

    International distribution to the country of Japan.

    Quantity

    6 units