BEUDAMED
    FDA Recall Terminated

    Pulmonary Hemi-Artery SG Used in heart surgery

    Recall: Z-0809-2014 · Initiated November 22, 2013

    Recall

    Recall Number
    Z-0809-2014
    Event Number
    67182
    Firm
    CryoLife, Inc.
    FEI Number
    3001451326
    Product Code
    DXZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 22, 2013
    Posted
    January 23, 2014
    Terminated
    February 20, 2014
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    Pulmonary Hemi-Artery SG Used in heart surgery

    Reason

    Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.

    Action

    CryoLife sent an Urgent Human Tissue Recall letter dated November 22, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact CryoLife to arrange for the return of the affected product. If the affected product had been implanted or discarded, customers should provide information regarding the status of the affected product on the attached self-addressed postcard. Customers with questions were instructedto contact the Field Assurance Department at 800-438-8285. For questions regarding this recall call 770-419-3355.

    Distribution

    US distribution in CA.

    Quantity

    One