BEUDAMED
    FDA Recall Terminated

    Labeling is as follows: Product Labeling: ''***Argon Medical Devices***12cc Control Syringe***FR/TR/RM w/ Reservoir***SINGLE USE ONLY***REF/REORDER NO. 093209***This device is designed for the administraion and removal of fluids.***Quantity: 250 ea.***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended******1445 Flat Creek Road Athens, TX 75751 800-927-4669***'' Carton Labeling: ''***Argon Medical Devices***12cc Control Syringe***FR/TR/RM w/ Reservoir***SINGLE USE ONLY***REF/REORDER NO. 093209***This device is designed for the administraion and removal of fluids.***Quantity: 250 ea***NON-STERILE*FURTHER PROCESSING REQUIRED***EtO (ethylene oxide) Sterilization Recommended***1445 Flat Creek Road Athens, TX 75751 800-927-4669***''

    Recall: Z-1080-05 · Initiated June 27, 2005

    Recall

    Recall Number
    Z-1080-05
    Event Number
    32510
    Firm
    Argon Medical Devices, Inc
    FEI Number
    1625425
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 27, 2005
    Posted
    August 3, 2005
    Terminated
    April 19, 2007
    Address
    1445 Flat Creek Rd, Athens, TX, 75751-5002

    Description

    Labeling is as follows: Product Labeling: ''***Argon Medical Devices***12cc Control Syringe***FR/TR/RM w/ Reservoir***SINGLE USE ONLY***REF/REORDER NO. 093209***This device is designed for the administraion and removal of fluids.***Quantity: 250 ea.***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended******1445 Flat Creek Road Athens, TX 75751 800-927-4669***'' Carton Labeling: ''***Argon Medical Devices***12cc Control Syringe***FR/TR/RM w/ Reservoir***SINGLE USE ONLY***REF/REORDER NO. 093209***This device is designed for the administraion and removal of fluids.***Quantity: 250 ea***NON-STERILE*FURTHER PROCESSING REQUIRED***EtO (ethylene oxide) Sterilization Recommended***1445 Flat Creek Road Athens, TX 75751 800-927-4669***''

    Reason

    The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip.

    Action

    The firm plans to distribute recall letters to all customers indicated on the customer list. TELEPHONE 6/27/2005. All products will be returned to Argon and disposed.

    Distribution

    TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS

    Quantity

    2752 syringes