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

  • Model / Serial
    Lot Number: U1753668.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including states of Georgia, Oregon and Texas.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Vance Products Incorporated, 1100 W Morgan St, Spencer IN 47460-9426
  • Manufacturer Parent Company (2017)
  • Source
    USFDA