Device Recall 10 cc NonSterile Syringe

  • Modelo / Serial
    Reorder #: 00-093207 - Lot #: 99442547
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS
  • Descripción del producto
    Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: || Product Label || ''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir SINGLE USE ONLY***REF/REORDER NO. 093205***This device is designed for the administration and removal of fluids***Quantity: 25ea***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended***1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***'' || Carton Label || ''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir SINGLE USE ONLY***REF/REORDER NO. 093205***This device is designed for the administration and removal of fluids***Quantity: 250ea***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended***1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***''
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Argon Medical Devices, Inc, 1445 Flat Creek Rd, Athens TX 75751-5002
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA