Children’s Medical Ventures is recalling its Gel-E Donut and Squishon 2 products used in hospitals to support and cradle an infant’s head or body because of numerous complaints about visible mold on the outer surface of the products. The mold was determined to be Cladosporium and Penicillium Fungi, commonly found molds.
Cladosporium can cause several different types of invasive infections including skin, eye, sinus and brain infections and those most vulnerable include newborns, critically ill patients, and patients with impaired or weakened immune systems. Both Cladosporium and Penicillium Fungi can cause difficulty breaking or allergic reaction. The recall is classified as a Class 1 because of the reasonable probability that use of the product could cause serious health consequences or death.
The round shape of the Gel-E Donut helps ease pressure caused by long periods of stillness or other conditions where frequent moving is not suggested. The rectangular shape of the Squishon 2 provides effective abdominal support when lying face down, and allows for head movement while maintaining a supportive surface.
Children’s Medical Ventures sent its customers an “Urgent – Field Safety Notice” informing them of the problem and actions that should be taken to prevent risks to patients. Affected products include Gel-E Donut model numbers 92025-A, 92025-B, and 92025-C. The affected Squishon 2 model is 91033-2.
Any adverse events or quality problems associated with these products should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.