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November 17, 2014 — The FDA has announced an expanded recall for the Gel-E-Donut and Squishon 2 infant gel pillows due to potential mold contamination.

The products were previously recalled in May 2014, but apparently manufacturing issues were not resolved. Since the original recall, one additional report of visible mold contamination has been received by the manufacturer, Philips Healthcare.

The latest recall involves products that were manufactured and distributed between July 2012 and August 2014. The mold contamination occurred during the manufacturing process. The mold types detected on the products are commonly found in indoor and outdoor environments.

According to the recall:

“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.”

Because the gel pillows are used on critically ill, premature, or newborn babies in a hospital setting, there is a higher risk that the mold will cause a life-threatening fungal infection.

The types of mold include Claposporidium and Penicillum Fungi, which can cause infections, breathing problems, and allergic reactions. Claposporidium is specifically associated with infections of the eye, skin, sinus, and brain.

The mold should be visible through the clear plastic packaging as black dots or splotches. However, you should not open the package to inspect the product.

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