BEUDAMED
    FDA Recall Terminated

    Bio-CORE Cannula (Needle) Set

    Recall: Z-1374-2015 · Initiated January 23, 2015

    Recall

    Recall Number
    Z-1374-2015
    Event Number
    70445
    Firm
    Biologic Therapies, Inc
    FEI Number
    3009790112
    Product Code
    FGY
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    January 23, 2015
    Posted
    April 2, 2015
    Terminated
    August 6, 2015
    Address
    5817 Nw 44th Ave, Ocala, FL, 34482-7891

    Description

    Bio-CORE Cannula (Needle) Set

    Reason

    Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution

    Action

    On January 23, 2015 the firm sent an URGENT: Class II MEDICAL DEVICE RECALL notification asking its consignees to: 1) Quarantine all remaining devices in their inventory and return the product to Biologic Therapies Inc. via UPS Ground. Product returns should be shipped under UPS Account #A197E9 and must reference RMA#15-0115-01. Please ship to the Biologic Therapies Inc. address listed at the bottom of Page 5. To coordinate return shipping, please contact Biologic Therapies, Inc. via the contact information provided.Contact hours: Monday - Friday 8am to 5pm Eastern Standard Time. (352) 304-5149 2) Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    Distribution

    US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.

    Quantity

    0 (distributed or released)