BEUDAMED
    FDA Recall Terminated

    "***Vipat REF H0020-100***Lot 100533***2015-04***STERILE EO Elastomeric pump***2mL/Hr***100mL***Medpro International (Thailand) Ltd. 360, Moo 6, Chonburi Industrial Estate, Tambon Bowin, Amphur Sriracha, Chonburi 20230, Thailand***Victus Inc. 4918 SW 74 Court 33155 44400***" Packed 24 units per case. The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.

    Recall: Z-0080-2012 · Initiated September 20, 2011

    Recall

    Recall Number
    Z-0080-2012
    Event Number
    59984
    Firm
    Victus, Inc.
    FEI Number
    3002843564
    Product Code
    MEB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 20, 2011
    Posted
    October 24, 2011
    Terminated
    January 12, 2012
    Address
    4918 SW 74th Ct, Miami, FL, 33155-4400

    Description

    "***Vipat REF H0020-100***Lot 100533***2015-04***STERILE EO Elastomeric pump***2mL/Hr***100mL***Medpro International (Thailand) Ltd. 360, Moo 6, Chonburi Industrial Estate, Tambon Bowin, Amphur Sriracha, Chonburi 20230, Thailand***Victus Inc. 4918 SW 74 Court 33155 44400***" Packed 24 units per case. The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.

    Reason

    Victus, Inc. Miami, FL is recalling Vipat Brand Elastomeric Infusion Pump, Model H0020-100, Lot 100533. The product may have a higher flow rate than specified. The use of this product may lead to over-administration of drug solutions to patients.

    Action

    Victus, Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated July 15, 2011 to affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use, remove the products from inventory and quarantine the products. Additionally, the firm indicated that their customer service department would contact customers to coordinate the return of affected products. Customers are directed to call 305-663-2129 ext. 110 for questions regarding this notice.

    Distribution

    USA (nationwide) including Puerto Rico and the states of FL and PA.

    Quantity

    63 units