Reported Aug 27, 2014 · Terminated
Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head…
Childrens Medical Ventures
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Childrens Medical Ventures · 191 Wyngate Dr · Monroeville, PA · 15146-3045
Is this the product you have?
- 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
- Lot codes and dates
- All lots of models
92025-A92025-B92025-C91033-2
- All lots of models
- Amount recalled
- 332,649
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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