Devices

Device Recall Boston Scientific

  • 모델명 / 제조번호(시리얼번호)
    Pouch codes for the 180 cm length wuidewires are:  Catalog No. 46-591, UPN M001465910 Lot Number Use Before Date 4959940 2005-08 4959941 '' 4969651 '' 4969654 '' 4969655 '' 4969656 ''  The pouch codes for the 260 cm length guidewires are: Catalog No. 46-5912, UPN M001465920 Lot Number Use Before Date 4959945 2005-08 4959946 '' 4959944 '' 4959943 ''
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed to 118 hospitals nationwide.
  • 제품 설명
    Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a sterile pouch and a three pack shelf box.
  • Manufacturer
    Symbiosis Corp.
  • 1 Event

제조사

Symbiosis Corp.
  • 제조사 주소
    Symbiosis Corp., 8600 NW 41th Street, Miami FL 33166
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 174 건

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Device Recall Boston Scientific, INGEVITY MRI Leads, Sterile EO, RxOnly.
  • 모델명 / 제조번호(시리얼번호)
    Model 7740  S/N 633464, 610662. Model 7741  S/N 657588, 563539, 628198, 636545, 641593, 656713, 656904. Model 7742  S/N 572200, 584869, 631202. Model 7732  S/N 488740. Model 7736  S/N 631322, 632188.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Distribution to the states of : IA and NY., and to the countries of : United Kingdom, Netherlands, Italy, Germany and Belgium.
  • 제품 설명
    Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
  • Manufacturer
    Boston Scientific Corporation
Device Recall Boston Scientific Imager II Angiographic Catheter
  • 모델명 / 제조번호(시리얼번호)
    Lot: 00112758, Use by 2018-05-11
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA, FL, KY, MO, NM, OK, OR, PA, and TX.
  • 제품 설명
    Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
  • Manufacturer
    Boston Scientific Corporation
Device Recall Boston Scientific/Microvasive
Device Recall Boston Scientific/Microvasive
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  5175575 5185073 5185074 5185075 5193211 5193212 5193213 5193920 5196902
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 유통
    Nationwide
  • 제품 설명
    Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/11.5 mm balloon || Catalog # 4545
  • Manufacturer
    Boston Scientific Corporation
Device Recall Boston Scientific/Microvasive
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