September 9, 2014 — Children’s Medical Ventures is recalling gel-filled infant pillows after receiving customer complaints about visible mold on the surface of the pillows that could cause invasive infections, especially in vulnerable infants.
The Class I Recall affects products that were sold between July 2012 and December 2013, including:
- Gel-E Donut: Round pillow, model numbers 92025-A, 92025-B, 92025-C.
- Squishon 2: Rectangular pillow, Model number 91033-2.
Two types of mold were discovered: Claposporidium and Penicillum Fungi. Both of these molds can cause invasive infections, breathing problems, and allergic reactions. Claposporidium is known to cause infections of the eye, skin, sinus, and brain.
The risk of infection is highest for very young infants, sick patients, or patients with compromised immune systems. Because the Gel-E Donut and Squishon 2 are commonly used in premature infants to reduce bilateral head flattening, there is a higher risk of infection. The FDA believes the use of these products could cause serious side effects, including death.
The manufacturer warned customers with an “Urgent Field Safety Notice” on May 28. According to the warning:
“Mold should be readily seen as black dots or splotches through the transparent outer packaging. Please do not open the packaging to do the inspection. If you are unsure or if the inspection is inconclusive, please err on the side of caution and designate that product as containing mold.”