Recall Z-2192-2014— Childrens Medical Ventures
Class I · Terminated
Class I FDA medical device recall by Childrens Medical Ventures, initiated 2014-05-28, terminated 2016-11-29. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Childrens Medical Ventures
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-05-28
- Terminated
- 2016-11-29
- Firm location
- Monroeville, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.