BEUDAMED
    FDA Recall Terminated

    The product is the "FASTx Sternal Intraosseous Device". The expiration date for the recalled products is end of June, 2012. The device is used to insert an infusion tube into the manubrium (upper portion of the sternum) of a patient. It is intended for intraosseous infusion as an alternative to intravenous access, to facilitate emergency resuscitation through the use of drugs and fluids. It is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.

    Recall: Z-2687-2011 · Initiated November 5, 2010

    Recall

    Recall Number
    Z-2687-2011
    Event Number
    59019
    Firm
    Pyng Medical Corporation
    FEI Number
    3003437923
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 5, 2010
    Posted
    June 28, 2011
    Terminated
    August 10, 2011
    Address
    13511 Crestwood Pl, Rm 7, Richmond Canada

    Description

    The product is the "FASTx Sternal Intraosseous Device". The expiration date for the recalled products is end of June, 2012. The device is used to insert an infusion tube into the manubrium (upper portion of the sternum) of a patient. It is intended for intraosseous infusion as an alternative to intravenous access, to facilitate emergency resuscitation through the use of drugs and fluids. It is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.

    Reason

    Device failed to operate; the insertion of the infusion tube of the FASTx Sternal Intraosseous Device was not achieved in live subjects.

    Action

    Pyng Medical Corp. sent a "FSN/RECALL FOR FASTx STERNAL INTRAOSSEOUS DEVICE, P/N FASTx -H" letter dated November 5, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers are to cease distribution and use of all devices. All devices remaining in inventory should be quarantined. Customers are asked to complete the information at the bottom of the letter and return the product by FEDEx. Questions regarding this notice should contact the Director of Operations at 1-604-303-7964 ext. 211.

    Distribution

    Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, England, Italy, Mexico, Poland, and Sweden.

    Quantity

    402 devices