Device Recall Turbo Elite 0.9mm Turbo Elite RX

  • Modelo / Serial
    Lot Number: 080417D.
  • Clasificación del producto
  • Distribución
    Nationwide Distribution including states of TX and FL.
  • Descripción del producto
    Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. Manufactured by Spectranetics, 96 Talamine Court, Colorado Springs, CO 80907. || The pouch label of the 1.4mm TE Over the Wire (OTW) catheter, Ref # 414-151, L/N# 080417D was incorrectly labeled for size as 0.9mm TE RX, Ref# 410-154, L/N#080417D. The box labels are correct and match the devices in the pouch. || The Spectranetics TURBO-BoosterTM guiding catheter is designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Spectranetics Corporation, 96 Talamine Ct, Colorado Springs CO 80907
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA