Philips Healthcare business unit Children's Medical Ventures (CMV) is voluntarily recalling all Gel-E Donut gel pillow and Squishon 2 gel cushion products, over potential mold contamination.
The latest action follows a previous recall for these products announced in May 2014. The recall has been initiated due to mold contamination of some products, which occurred during the manufacturing process.
CMV said that it implemented a process intended to reduce the presence of viable mold on the products prior to shipment, at the time the initial recall.
The Gel-E Donut gel pillow and Squishon 2 gel cushions have been developed to provide support for infant’s head or body in a hospital environment.
The products can be used in Neonatal Intensive Care Units (NICU), Pediatric Intensive Care Units (PICU), and neonatal care centers.
According to Philips Healthcare, the affected products have been shipped to countries, including the US, Australia, Austria, Belgium, Canada, France, Germany, Iceland, Ireland and Italy.
In addition, the products are supplied in Japan, Kuwait, Netherlands, New Zealand, Norway, Portugal, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand and the UK.
Image: The Children’s Medical Ventures Gel-E Donut. Photo: courtesy of PRNewswire/ Philips Healthcare.