BEUDAMED
    FDA Recall Open, Classified

    Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312

    Recall: Z-3128-2024 · Initiated July 9, 2024

    Recall

    Recall Number
    Z-3128-2024
    Event Number
    95152
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DWF
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 9, 2024
    Posted
    September 12, 2024
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312

    Reason

    During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).

    Action

    Medtronic issued an Urgent: Medical Device Recall notice to its consignees on 07/09/2024 via UPS. The notice explained the issue, potential risk, and requested return of the affected device. Those who further distributed the device were directed to share the notice with those to whom the affected product was distributed.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam.

    Quantity

    290 units