BEUDAMED
    FDA Enforcement Class II Terminated

    Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881850558

    Recall: Z-1250-2021 · Reported March 24, 2021

    Enforcement

    Recall Number
    Z-1250-2021
    Event ID
    87313
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 24, 2021
    Initiation Date
    February 9, 2021
    Classification Date
    March 15, 2021
    Termination Date
    April 9, 2024
    Address
    15 Hampshire St Bldg 5, N/A, Mansfield, MA, 02048-1113, United States

    Description

    Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881850558

    Reason

    Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens

    Code Info

    Lot Code: 025221

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of AE, Japan.

    Quantity

    243,250 units