Recall Z-2192-2014
Childrens Medical Ventures · initiated May 28, 2014
Class I – dangerous or defective products that could cause serious health problems or death
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.
Codes / lots: All lots of models: 92025-A, 92025-B, 92025-C, 91033-2
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.
FDA-determined cause: Material/Component Contamination
Action taken
Childrens Medical Ventures sent an Urgent Medical Device Recall letter dated May 28, 2014, to affected customers via UPS. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to review entire inventory and inspect for signs of visible mold, do not open the packaging to do the inspection, the mold should be seen through the transparent outer packing, complete and return the reply form provided on the last page of the letter, dispose of any product containing mold per your facilitys environmental guidelines, do not return any product to your Distributor or to Philips/Childrens Medical Ventures.and credit for disposed product will be given. If you need any further information or support concerning this problem, please contact your Distributor at the following phone number:
Details
- Recall number
- Z-2192-2014
- Initiated
- May 28, 2014
- Posted by FDA
- August 20, 2014
- Terminated
- November 29, 2016
- Product code
- FMP – Protector, Skin Pressure
- Quantity
- 332,649
- Distribution
- Worldwide Distribution - USA (nationwide) including the country of Canada.
- Recalling firm
- Childrens Medical Ventures, Monroeville, PA