Mold Fears Lead to Gel-E-Donut and Squishon 2 Infant Pillow Recall
More than 330,000 newborn neck cradle support cushions are being recalled, following multiple reports of visible mold on the outer surfaces, which may pose a risk of severe adverse consequences for infants.
On August 21, the FDA announced that it was giving a Gel-E Donut and Squishon 2 gel cushion recall a class 1 designation, which suggests that continued use of the products may pose a risk of serious injury or death.
The infant pillows were initially recalled on May 28, following reports from hospitals nationwide that two dangerous types of mold were visibly growing on the products.
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The Gel –E Donut and Squishon 2 products are gel-filled cushions that are round in shape and designed to give support to newborn where frequent moving is not suggested. The Gel-E Donut cushions sit under a newborns head to give support and cradle an infant’s neck and body whereas the Squishon 2 cushions are rectangular shape and provide abdominal support when the infant is lying face down, allowing for head movement while maintaining a supportive surface.
In the reports submitted to the manufacturer, the two types of mold found to be growing in the cushions were determined to be Cladosporium and Penicillium Fungi molds. Cladosporium mold exposure can be extremely dangerous for newborns. It can cause several different types of invasive infections, including skin, eye, sinus, and brain infections; especially to those with weakened immune systems. The Penicillium Fungi is an invasive mold that may cause breathing difficulties and severe allergic reactions.
The FDA advised that the mold should be identifiable to the naked eye because it will appear as black spots or blotches on the cushions. The FDA has also advised customers to err on the side of caution and remove the cushions, as children may lay on them and have direct contact or be breathing in the infections.
The recall includes an estimated 332,649 of both the Gel-E Donut and Squishon 2 cushion models. The recalled includes all lots of both model types and includes the model numbers 92025-A, 9205-B, and 92025-C for the Gel-Donut models and model number 91033-2 for the Squishon 2 models.
The cushions were manufactured by Children’s Medical Ventures, of Monroeville, Pennsylvania where they were sold and distributed to hospital across the nation and in Canada from July 1, 2012 to December 31, 2013.
The FDA has classified this recall as “Class I”, which is the most serious type and involves situations in which there is a reasonable probability that the use of the products will cause serious adverse health consequences or even death.
Children’s Medical Ventures has sent Urgent Field Safety Notice’s informing customers and distributors of the problem and the actions to be taken to prevent the mold from infecting patients. In the warning notice the manufacturer asks customers to review their entire inventory of both model cushions by looking through the plastic wrapping for mold indicators. Customers should then fill out the “Reply Form” documents and return them through email at firstname.lastname@example.org or fax them over to 1-404-855-4900.
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