Infant Hospital Pillow Recall Expanded Due to Risk of Mold on Gel-E-Donut, Squishon 2

Newborn neck cradle support cushions used at hospitals throughout the U.S. have been recalled, due to potential mold contamination that may pose a serious health risk for infants.

Following an infant hospital pillow recall initially issued in May 2014, the FDA announced last week that additional Gel-E-Donut and Squishon 2 gel cushions are being recalled, after new reports by health care workers who detected the presence of mold. The recall now includes an estimated 336,694 infant pillows and cushions sold worldwide.

The Gel –E Donut and Squishon 2 products are gel-filled cushions that are round in shape and designed to provide support to newborns, when frequent moving is not suggested. The Gel-E Donut cushions sit under a newborns head to give support and cradle an infant’s neck and body, whereas the Squishon 2 cushions are rectangular shape and provide abdominal support when the infant is lying face down, allowing for head movement while maintaining a supportive surface.

The initial recall was issued earlier this year by Children’s Medical Ventures, the manufacturer of the hospital infant pillows, following multiple reports from neonatal intensive care units (NICU) and pediatric intensive care units (PICU) hospital units that indicated there was visible presence of mold in the shape of black spots.

After further evaluation, the mold was identified as Cladosporium and Penicillium Fungi, which are molds commonly found indoor and outdoor molds that have the potential to be transferred to patient environments once the packaging of the cushions was opened.

Cladosporium mold exposure can be extremely dangerous for newborns. It can cause several different types of invasive infections, including skin, eye, sinus, and brain infections; especially to those with weakened immune systems. The Penicillium Fungi can also be extremely dangerous to infants due to the breathing difficulties and severe allergic reactions.

The FDA quickly prompted the manufacturer to recall the products to prevent newborns already fighting for their lives from potentially suffering life-threatening infections due to exposure to the mold.

New Process To Prevent Mold Failed

Following the initial recall, Children’s Medical Ventures implemented a new process intended to reduce the presence of viable mold on the products prior to shipment. However, since the new process has been implemented, the FDA has received at least one additional report of mold growth within the product packaging at a hospital, which suggests that the new process has not adequately addressed the possibility of mold growth, leading to the total recall of hospital infant pillows made by the company on November 14.

The recall now includes all lots of Gel-E Donut and Squishon 2 cushion models, which includes model numbers 92025-A, 9205-B, and 92025-C for the Gel-Donut models and model number 91033-2 for the Squishon 2 models.

The products were manufactured by Children’s Medical Ventures of Andover, Massachusetts and were distributed to NICUs and PICUs at hospitals between July 2012 and August 2014. The cushions were shipped throughout the Unites States and Australia, Austria, Belgium, Canada, France, Germany, Iceland, Ireland, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Portugal, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand and United Kingdom.

The FDA has classified this recall as “Class I”, which is the most serious type and involves situations where the agency determines that use of the product poses a reasonable probability of serious adverse health consequences or even death.

In an Urgent Field Safety Notice sent by Children’s Medical Ventures in May 2014, customers were encouraged to review their entire inventory of both model cushions by looking through the plastic wrapping for mold indicators. Customers should then fill out the “Reply Form” documents and return them through email at gelrecall@phillips.com or fax them over to 1-404-855-4900. Customers with questions may also contact their local Philips Representative at 770-510-4681 or 770510-4684.