The recalled products were manufactured and distributed between July 2012 and August 2014.
The move follows a previous recall for these products announced in May, due to mould contamination of some products, which occurred during the manufacturing process.
At the time of initial recall, the company implemented a process intended to reduce the presence of viable mould on the products prior to shipment.
Gel-E Donut gel pillow and Squishon 2 gel cushions were developed to provide support for an infant’s head or body in a hospital environment.
The products can also be used in Neonatal Intensive Care Units (NICU), Pediatric Intensive Care Units (PICU) and neonatal care centres.
CMV is asking customers to stop using and dispose of all Gel-E Donut gel pillow and Squishon 2 gel cushion products in their facility, even if mould is not visible.
According to the company, the affected products were shipped to countries, including the US, Australia, Austria, Belgium, Canada, France, Germany, Iceland, Ireland and Italy.
Additionally, 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.
The company said that adverse reactions or quality problems experienced with the use of this product should be reported to FDA’s MedWatch Adverse Event Reporting programme.
Image: The Children’s Medical Ventures Gel-E Donut. Photo: courtesy of PRNewswire / Philips Healthcare.