Mold In Infant Pillows Even After Process Change; Worldwide Recall

Children’s Medical Ventures, a Philips Healthcare business based in Andover, Massachusetts, recalled all Gel-E Donut gel pillow and Squishon 2 gel cushion products due to potential mold contamination of the products. The recalled model numbers are 92025-A, 92025-B, 92025-C, and 91033-2.  These were manufactured and distributed between July 2012 and August 2014. The model number is printed directly on the product.  There were 336,695 units involved.


In May 2014, Children’s Medical Ventures initiated a recall due to mold contamination of some products, which occurred during the manufacturing process. The mold types detected on the products have been identified as types which are commonly found in indoor and outdoor environments. There is potential for the mold to be transferred to patient environments once the outer pack is opened. There is the possibility of fungal infection should patients come in contact with the mold, which could be superficial or invasive and life threatening.


At the time of the initial recall, Children’s Medical Ventures implemented a process intended to reduce the presence of viable mold on the products prior to shipment. Since then, Philips has received one new report of the presence of mold on a product. Because the process to eliminate the potential for mold growth has not been fully effective, the company is announcing this new recall.


The Children’s Medical Ventures Gel-E Donut gel pillow and Squishon 2 gel cushions are intended to help support an infant’s head or body in a hospital environment. The products are intended to be used in Neonatal Intensive Care Units (NICU), Pediatric Intensive Care Units (PICU), and neonatal care centers.


Countries where affected devices have been shipped include the United States, 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 the United Kingdom.


See the Recall


See also Medical Law Perspectives, January 2012 Report: Hospital-Acquired Infections: Who Is Liable and Why?