FDAFDA · Alimentos y medicamentos·N.º oficial 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.
Publicado el 27 de agosto de 2014 · Inicio del retiro: 28 de mayo de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Childrens Medical Ventures
- Distribuidor
- Worldwide Distribution - USA (nationwide) including the country of Canada.
- Lote
- All lots of models: 92025-A, 92025-B, 92025-C, 91033-2
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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