BEUDAMED
    FDA Recall Terminated

    Convenience Kits containing Inject8 or Inject10 syringes.

    Recall: Z-0050-05 · Initiated September 14, 2004

    Recall

    Recall Number
    Z-0050-05
    Event Number
    30119
    Firm
    Merit Medical Systems, Inc
    FEI Number
    1721504
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 14, 2004
    Posted
    October 28, 2004
    Terminated
    March 31, 2005
    Address
    1600 Merit Pkwy South, Jordan, UT, 84095-2416

    Description

    Convenience Kits containing Inject8 or Inject10 syringes.

    Reason

    Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.

    Action

    All consignees were notified by telephone and letter on 9/14/2004. A second letter, dated 11/24/04, was also sent to consignees.

    Distribution

    Nationwide. One VA facility in NC, one military hospital in GA. Foreign distribution to Canada, France, Japan, Netherlands.

    Quantity

    143 kits