BEUDAMED
    FDA Recall Terminated

    OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma.

    Recall: Z-1083-2010 · Initiated April 20, 2009

    Recall

    Recall Number
    Z-1083-2010
    Event Number
    54512
    Firm
    OPTI Medical Systems, Inc
    FEI Number
    3004102403
    Product Code
    CGZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 20, 2009
    Posted
    March 11, 2010
    Terminated
    April 17, 2012
    Address
    235 Hembree Park Dr, Roswell, GA, 30076-5738

    Description

    OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma.

    Reason

    Outer box labeling shows an incorrect storage temperature range.

    Action

    OPTI Medical Systems, Inc. issued a "Medical Device Correction" letter dated April 20, 2009. Consignees were instructed on how to corrected the affected product and were asked to return a completed Correction Response Card. For further information, contact OPTI Medical Systems, Inc. at +01 770 510 4444 (outside US) or 1-800-490-6784 (US).

    Distribution

    Worldwide Distribution -- United States (CA, KY, MA and OK), Djouti (Africa), Egypt, Guatemala, India, Iraq, Pakistan, United Arab Emirates and Vietnam.

    Quantity

    127 boxes of 25 cassettes each for a total of 3175 cassettes.