Device Recall Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: U1753668.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including states of Georgia, Oregon and Texas.
  • 제품 설명
    Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological Inc., Spencer, IN; REF USH-526-R, GPN REF G49966. The product was placed in a shipping box which is preprinted with the word "firm" instead of "soft", but a product specific label stating "soft", as above, was also placed on the box. || The ureteral stent is used for temporary drainage from the ureteropelvic junction to the bladder.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Vance Products Incorporated, 1100 W Morgan St, Spencer IN 47460-9426
  • 제조사 모회사 (2017)
  • Source
    USFDA