Device Recall 27023WU Balloon Catheter

  • Model / Serial
    Lots: 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, 08451.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US distribution to: AZ, FL, IL, IN and TX.
  • Product Description
    27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. || The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Karl Storz Endoscopy America Inc, 15 Wells St, Southbridge MA 01550-4503
  • Manufacturer Parent Company (2017)
  • Source
    USFDA