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A recall has been issued for Children’s Medical Ventures, Gel-E Donut and Squishon 2. 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 use of affected product may cause serious adverse health consequences, including death. For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm410964.htm
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