BEUDAMED
    FDA Recall Terminated

    Pulstar(R) DVT PREVENTION SYSTEM, Anti-Embolism Wrap System, albahealth(R), A Subsidiary of Encompass Group, LLC. Prevention of DVT.

    Recall: Z-0183-2012 · Initiated October 12, 2011

    Recall

    Recall Number
    Z-0183-2012
    Event Number
    60122
    Firm
    Albahealth LLC
    FEI Number
    1043612
    Product Code
    JOW
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    October 12, 2011
    Posted
    November 14, 2011
    Terminated
    March 30, 2012
    Address
    425 N Gateway Ave, Rockwood, TN, 37854-2336

    Description

    Pulstar(R) DVT PREVENTION SYSTEM, Anti-Embolism Wrap System, albahealth(R), A Subsidiary of Encompass Group, LLC. Prevention of DVT.

    Reason

    The wrap portion of the device was tearing at the seam.

    Action

    Albahealth, L.L.C. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 19, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory and to quarantine all affected product. A response form was enclosed for customers to complete and return. The firm provide information on how to return the affected product and receive replacement product. Questions concerning this recall are directed to call 865-354-5229 for assistance.

    Distribution

    Nationwide Distribution- including the states of CA, CO, FL, GA, IN, KY, LA, NY, OH, PA, TX, and TN.

    Quantity

    2,582 pairs