BEUDAMED
    FDA Recall Terminated

    Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.

    Recall: Z-1075-2010 · Initiated November 6, 2009

    Recall

    Recall Number
    Z-1075-2010
    Event Number
    53880
    Firm
    Medical Action Industries Inc
    FEI Number
    1030451
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 6, 2009
    Posted
    March 30, 2010
    Terminated
    June 1, 2011
    Address
    25 Heywood Rd, Arden, NC, 28704-9302

    Description

    Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.

    Reason

    Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.

    Action

    On 11/6/2009 a letter was drafted and sent by email to three (3) Medical Action Industries customers. They were instructed to return the recalled products in inventory to MAI. They further advised, if the product was distributed to notify their customer, inform them of the recall and instruct them to return the affected lots to MAI.

    Distribution

    Nationwide distribution

    Quantity

    2,520 kits