Z-2192-2014 Class I Terminated
FDA device recall Z-2192-2014 was initiated by Childrens Medical Ventures on May 28, 2014 and is designated Class I. Reason for recall: 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 commo… The recall status is terminated (terminated November 29, 2016). Affected quantity: 332,649.
Recall Details
- Product Type
- Devices
- Report Date
- August 27, 2014
- Initiation Date
- May 28, 2014
- Termination Date
- November 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 332,649
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) including the country of Canada.
Code Information
All lots of models: 92025-A, 92025-B, 92025-C, 91033-2