BEUDAMED
    FDA Recall Open, Classified

    Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture/collagen-based hemostatic devices.

    Recall: Z-1611-2023 · Initiated April 12, 2023

    Recall

    Recall Number
    Z-1611-2023
    Event Number
    92090
    Firm
    TELEFLEX LLC
    FEI Number
    3005747797
    Product Code
    MGB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 12, 2023
    Posted
    May 18, 2023
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    Description

    Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture/collagen-based hemostatic devices.

    Reason

    The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.

    Action

    Teleflex issued an URGENT - MEDICAL DEVICE RECALL notice to its consignees on 04/12/2023 via FedEx 2nd day. The notice explained the issue and the hazard and requested the following actions be taken: Medical Facilities - immediately check your inventory for product within the scope of this recall. Users should cease use and distribution of affected product and immediately quarantine the affected product. If impacted product is on hand, mark the applicable checkbox on the Acknowledgement Form and fax it to 1-855-419-8507, including Attn: Customer Service or using the email address [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. Distributors were directed to immediately check your inventory for product within the scope of this recall. Users should cease use and distribution of affected product and immediately quarantine the affected product. They were further directed to notify their customers, collect the response forms, and upon completion of the action forward the completed Acknowledgement Form to [email protected].

    Distribution

    US Nationwide

    Quantity

    1140 units