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.
Enforcement
- Recall Number
- Z-2192-2014
- Event ID
- 68443
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Childrens Medical Ventures
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 27, 2014
- Initiation Date
- May 28, 2014
- Classification Date
- August 20, 2014
- Termination Date
- November 29, 2016
- Address
- 191 Wyngate Dr, Monroeville, PA, 15146-3045, United States
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.
The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fungi, which are commonly found molds.
All lots of models: 92025-A, 92025-B, 92025-C, 91033-2
Worldwide Distribution - USA (nationwide) including the country of Canada.
332,649