Device Recall GentleTouch System Postoperative Kit

  • Model / Serial
    Lot Numbers: 7G29699, 7G30740, 7G31418, 7H22693, 7H24608, 7J30626, 7J32192 and 7K30871. Lot numbers 7L27391, 8A33519 and 8A37099 are also affected, however they have not been distirbuted.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and country of Canada.
  • Product Description
    GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ 08558.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    ConvaTec, 200 Headquarters Park Dr, Skillman NJ 08558-2624
  • Source
    USFDA