Children’s Medical Ventures received a number of complaints about visible mold on the outer surface of Gel-E Donut and Squishon 2 gel-filled products. The detected mold was determined to be Cladosporium and Penicillium Fungi, commonly found molds. Cladosporium has been known to cause several different types of invasive infections, including skin, eye, sinus, and brain infections especially in vulnerable populations such as neonates, critically ill patients, and patients with an impaired or weakened immune system. Cladosporium and Penicillium Fungi can also cause difficulty in breathing or allergic reaction.
The Gel-E Donut and Squishon 2 gel-filled products are used in hospitals, under the supervision of a caregiver, to support and cradle an infant’s head and/or body. 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 downward (prone position) and allows for head movement while maintaining a supportive surface.
The affected products were manufactured and distributed from July 1, 2012, to December 31, 2013. The model numbers for the recalled Gel-E Donut are 92025 A, 92025 B and 92025 C. The model number for the Squishon 2 is 91033-2.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall