Philips Healthcare initially recalled its Gel-E Donut and Squishon 2 medical devices in May 2014 after visible mold was detected on the outer surface of the products. This recall was for devices distributed from July 2012 to December 2013.
As of October 2014, the Food and Drug Administration (FDA) reported a Class I recall issued by the same manufacturing company for the same devices. These gel-filled products are used under supervision in hospitals to support an infant's head and body. The following models have been recalled:
- Gel-E Donut 92025-A;
- Gel-E Donut 92025-B;
- Gel-E Donut 92025-C; and
- Squishon 2 91033-2.
The second recall included products manufactured from July 2012 through to August 2014. The defective devices prompted 12 new complaints of visible mold within just four months of the initial recall. Cladosporium and Penicillium Fungi were two of the molds identified, which can cause:
- Skin, eye, brain, and sinus infections;
- Difficulty breathing; and
- Allergic reactions.
These risks increase for infants in intensive care units due to their heightened sensitivity to mold. Mold can spread between care units by simply opening the packaging of these products.
A Class I recall is issued when there are conditions that lead to reasonable probability that the products will cause serious health complications or death. It is the most serious of product recalls issued by the FDA. Why were the Gel-E Donut or Squishon 2 not investigated more thoroughly before continuing their manufacturing and distribution?
The FDA now warns against use of any Gel-E Donut or Squishon 2 product regardless of the visibility of mold.
A baby's immune system is fragile and parents are dedicated to ways to help boost their development and prevent infection. A medical device recall such as this puts babies in danger before they ever leave the hospital. Parents should not have to be subject to this type of product defectiveness when it comes to the care of their child.
Our attorneys are experienced in litigating against large manufacturing companies and we are dedicated to fighting for our clients. If your child has been injured as a result of a defective medical device in Illinois, contact an experienced Chicago medical malpractice attorney. Call the law office of [[title]] at [[phone]] for a free case evaluation.