BEUDAMED
    FDA Recall Terminated

    PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Introducer Sheath PINNACLE R/O II Radiopaque Marker Introducer Sheath

    Recall: Z-2738-2016 · Initiated March 16, 2016

    Recall

    Recall Number
    Z-2738-2016
    Event Number
    73833
    Firm
    Terumo Medical Corporation
    FEI Number
    1118880
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 16, 2016
    Posted
    September 6, 2016
    Terminated
    January 27, 2017
    Address
    950 Elkton Blvd, Elkton, MD, 21921-5322

    Description

    PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Introducer Sheath PINNACLE R/O II Radiopaque Marker Introducer Sheath

    Reason

    Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve.

    Action

    Terumo sent an Urgent Product Recall Bulletin dated March 7, 2016, to all affected customers. All affected customers will be notified regarding the required recall actions (stop using/quarantine the affected products). TMC will strive for 100% verification to confirm that all customers have acknowledged the recall. Follow-up communication is being sent specifying the mechanisms to be used for labeling and returning the involved product from the customer level. We regret any inconvenience this action may cause your operations and we appreciate your understanding. Please contact us if you need assistance procuring additional inventory. We are committed to continuing to offer products that meet the highest quality standards that you expect from Terumo Medical Corporation. If you have questions or need further information, please call Customer Care at 1-800-888-3786 or contact your local sales representative. For further questions regarding this recall please call (410) 392-7226.

    Distribution

    Nationwide Distribution

    Quantity

    1,370,995 eaches have been distributed to the field