Device product
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.
Z-2192-2014
Product summary
- Event
- Event 68443
- Status
- Terminated
- Classification
- Class I
- Quantity
- 332,649
- Official record key
device-enforcement:Z-2192-2014
Official wording
Reason: 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.
Code information: All lots of models: 92025-A, 92025-B, 92025-C, 91033-2
Distribution pattern: Worldwide Distribution - USA (nationwide) including the country of Canada.
Derived failure modes
-
Microbial contamination
detected was determined to be Cladosporium and Penicillium