Devices

Device Recall GelE Donut, Squishon 2

Model / Serial
All lots of models: 92025-A, 92025-B, 92025-C, 91033-2
Product Classification
General Hospital and Personal Use Devices
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
Childrens Medical Ventures
1 Event
- Recall of Device Recall GelE Donut, Squishon 2

Manufacturer

Childrens Medical Ventures

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

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