Device product
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.
Z-0206-2015
Product summary
- Event
- Event 69568
- Status
- Terminated
- Classification
- Class I
- Quantity
- 336,695 units
- Official record key
device-enforcement:Z-0206-2015
Official wording
Reason: Mold on gel filled Gel-E and Squishon products
Code information: All lot codes
Distribution pattern: 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.
Derived failure modes
-
Unknown
Mold on gel filled Gel-E and Squishon products