Device Recall TEM Disposable Tube Set

  • Modèle / numéro de série
    Part Number 4170.801, Lot Number 060232
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution --- including the states of Alabama, Florida, District of Columbia, Michigan, Minnesota, Nebraska, New York, Ohio, Oregon, Pennsylvania, Utah, Vermont and Wisconsin.
  • Description du dispositif
    Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring tube, an insufflation tube, an irrigation tube, a suction tube, a pump tube, and a connection tube; a sterile, disposable, single use accessory to the TEM (Transanal Endoscopic Microsurgery) System used for insufflation of the rectal cavity; Manufacturer: Richard Wolf GmbH, Postfoch 1164, D-75343 Knittlingen, Deutschland; Product Number 4170.801
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Richard Wolf Medical Instruments Corp., 353 Corporate Woods Pkwy, Vernon Hills IL 60061-3110
  • Société-mère du fabricant (2017)
  • Source
    USFDA