FDAFDA · Food and drugs·Recall number Z-2192-2014
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.
Published August 27, 2014 · Recall initiated: May 28, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Childrens Medical Ventures
- Distributor
- Worldwide Distribution - USA (nationwide) including the country of Canada.
- Lot
- All lots of models: 92025-A, 92025-B, 92025-C, 91033-2
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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