Devices

Device Recall 10cc Nonsterile Manifold Kit

  • Modelo / Serial
    Reorder #: 00-094337 - Lot #: 99442306 Reorder #: 00-094367 - Lot #: 99443999 Reorder #: 00-094367 - Lot #: 99444179
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS
  • Descripción del producto
    Labeling is as follows: || Product Labeling: || ''***Argon Medical Devices***MANIFOLD KIT***SINGLE USE ONLY***REF/REORDER NO. 094337***EtO STERILIZATION RECOMMENDED***Caution: For manufacturing, processing or repacking.***1445 Flat Creek Road Athens, TX 75751 800-927-4669***'' || Carton Labeling: || ''***Argon Medical Devices***MANIFOLD KIT***SINGLE USE ONLY***REF/REORDER NO. 094337***Quantity: 20 ea***NON-STERILE*FURTHER PROCESSING REQUIRED***EtO (ethylene oxide) Sterilization Recommended***1445 Flat Creek Road Athens, TX 75751 800-927-4669***''
  • Manufacturer
    Argon Medical Devices, Inc
  • 1 Event

Fabricante

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