Two products used by hospitals for premature babies, the Gel-E Donut and Squishon 2, were recalled when mold was reportedly detected, specifically Cladosporium and Penicillium Fungi. Cladosporium can cause invasive infections of the eyes, skin, sinuses and brain. Cladosporium and Penicillium Fungi can cause difficulty breathing or allergic reaction. Both molds can cause fatal infections. There have been no reports of illnesses associated with these products at this time.
“When a contaminated medical product causes illness, the company that made that product should be held accountable,” said Fred, who recently won $45,000,000.00 for clients injured by another medical product made by another company. Fred is also currently representing several families whose newborn babies were severely sickened after using another medical product.
Gel-E Donut and Squishon 2 Recall Details
The manufacturer of the recalled Gel-E Donut and Squishon 2 products is Children’s Medical Ventures, a company owned by medical product company Koninklijke Philips N.V. (Philips). The recalled products include the following:
- Gel-E Donut – Model Numbers: 92025-A, 92025-B, 92025-C
- Squishon2 – Model Number: 91033-2
The recalled Gel-E Donut and Squishon 2 products were recalled after Philips received a number of complaints about visible mold on the outer surface of certain of these products. Tests done on the mold found them to be Cladosporium and Penicillium Fungi. The U.S. Food and Drug Administration (FDA) is warning hospitals that use of the recalled products may cause serious adverse health consequences, including death.
The recalled products were manufactured and distributed from July 1, 2012 to December 31, 2013. They were sold to hospitals.
What are the Gel-E-Donut and Squishon 2 Products?
The Gel-E Donut is used in hospitals to support a baby’s head. As suggested by its name, it is gel-filled. The gel, a non-toxic substance, is in a round, soft outer bag.
The Squishon 2 is used for abdominal support for babies who are lying face downward (prone position). It is also filled with a non-toxic gel.
As stated above, the complaints were of mold on the outer surface of these products. When alerted to the problem, the company sent an “Urgent – Field Safety Notice” informing affected customers, end users, and distributors of the problem.