Device Recall GelE Donut, Squishon 2

  • Model / Serial
    All lots of models: 92025-A, 92025-B, 92025-C, 91033-2
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the country of Canada.
  • Product Description
    Gel-E Donut, Squishon 2 gel pillows || Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Childrens Medical Ventures, 191 Wyngate Dr, Monroeville PA 15146-3045
  • Source
    USFDA