FDAFDA · Food and drugs·Recall number Z-0206-2015
Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body.
Published December 3, 2014 · Recall initiated: October 10, 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
Mold on gel filled Gel-E and Squishon products
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to: Canada, Australia, Austria, Belgium, France, Germany, Iceland, Ireland, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Portugal, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, and the United Kingdom.
- Lot
- All lot codes
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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