Children’s Medical Ventures is recalling all Gel-E Donut gel pillows and Squishon 2 gel cushion products used to help support an infant’s head or body in neonatal or pediatric intensive care units because the products may be contaminated with mold. This issue could cause invasive and life threatening fungal infections to critically ill babies.
Children’s Medical Ventures, a Phillips Healthcare business, said the contamination occurred during the manufacturing process. The mold types detected have been identified as types that are commonly found outdoors. The presence of the mold on the pillows and cushions can be transferred to patient environments once the outer pack is opened.
The company issued a recall of the same two products in August after receiving numerous customer complaints about visible mold on the outer surface of the pillows and cushions. The mold was determined to be Cladosporium and Penicillium Fungi, commonly found molds that can cause several different types of invasive infections including skin, eye, sinus and brain infections. Complications include difficulty breathing or allergic reactions.
The company has not announced what type of mold is present in the latest pediatric support pillows recall.
Hospitals with Gel-E Donut gel pillows and Squishon 2 gel cushion products affected by the recall should discontinue use and dispose of the products even if mold is not present. Health care professionals and caregivers should report any adverse events or quality problems to the Food and Drug Administration (FDA) at www.FDA.gov/MedWatch/Report.htm.