Expect Endoscopic Ultrasound Aspiration Needle

  • Modèle / numéro de série
    Lot/Batch Number: 7442099.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Description du dispositif
    Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 25GA (0.52 mm) sterile, UPN M00550021, 5 pack, 428 Technology Drive East, Menomonie, WI. || Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA

4 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot: 13615651C1; UPN M00550020
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of VT, FL, SC, NC, WA, MA, and MN.
  • Description du dispositif
    Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Use By 1999-12 LOT 13615651C1 STERILE EO || The Expect Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
  • Manufacturer
  • Modèle / numéro de série
    Lot/Batch Numbers: 7860533, 7982702 and 7983132.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Description du dispositif
    Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 22GA (0.72 mm) sterile, UPN M00550010, 428 || Technology Drive East, Menomonie, WI. || Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
  • Manufacturer
  • Modèle / numéro de série
    Lot/Batch Numbers: 7441839 and 7442099.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Description du dispositif
    Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 25GA (0.52 mm) sterile, UPN M00550020, 428 Technology Drive East, Menomonie, WI. || Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
  • Manufacturer
  • Modèle / numéro de série
    Lot/Batch Numbers: 7860533 and 7983132.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Description du dispositif
    Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm) sterile, UPN M00550011, 5 pack, 428 Technology Drive East, Menomonie, WI. || Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
  • Manufacturer