November 17, 2014 — After receiving yet another report of visible mold contamination, Philips Healthcare is expanding a recall of the Gel-E-Donut and Squishon 2 infant gel pillows due to the risk of infection.
The pillows are used in a hospital setting to support the head of premature infants, who are more susceptible to invasive fungal infections. The FDA issued a Class I recall for the products in May, but apparently manufacturing issues were not resolved. Click here to read more.
The latest recall involves products manufactured and distributed between July 2012 and August 2014, including model numbers 92025-A, 92025-B, 92025-C, and 91033-2. About 336,695 products are affected by the recall.
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.”
Mold contamination should look like black dots or splotches visible through the clear plastic packaging, but the manufacturer warns against opening any of the affected products.
According to the previous recall, manufacturing problems were responsible for introducing molds that are commonly found in the environment. Infections with Penicillum Fungi can lead to skin infections, breathing problems, and allergic reactions. The Claposporidium mold is associated with infections of the eye, skin, sinus, and brain.