Product Model Numbers Gel-E Donut 92025-A, 92025-B, 92025-C Squishon 2 91033-2

[Posted 08/22/2014]

AUDIENCE:Pediatrics, Risk Manager

ISSUE: FDA and Childrens Medical Ventures, Monroeville, PA notified health professionals and their health delivery organizations of a class 1 recall of this product due to complaints about visible mold on the outer surface of Gel-E Donut and Squishon 2 gel-filled products. The detected mold was determined to be Cladosporium and Penicillium Fungi, commonly found molds. Cladosporium has been known to cause several different types of invasive infections, including skin, eye, sinus, and brain infections especially in vulnerable populations such as neonates, critically ill patients, and patients with an impaired or weakened immune system. Cladosporium and Penicillium Fungi can also cause difficulty in breathing or allergic reaction. The use of affected product may cause serious adverse health consequences, including death.

BACKGROUND: These gel-filled products are used in hospitals, under the supervision of a caregiver, to support and cradle an infants head and/or body, help ease pressure caused by long periods of stillness and allow for head movement while maintaining a supportive surface.The affected products were manufactured and distributed from July 1, 2012 to December 31, 2013.

RECOMMENDATION: On May 28, 2014, Childrens Medical Ventures sent an UrgentField Safety Notice informing affected customers, end users, and distributors of the problem, actions that should be taken by the customer/product user in order to prevent risks to patients, and the actions planned by Philips/Childrens Medical Ventures to correct the problem.

Please see the Class 1 recall notice below for detailed instructions provided by Childrens Medical Ventures for customers/product users and for distributors.

For questions about this recall, contact Childrens Medical Ventures Customer Support at 412-380-8881.

[08/21/2014 - Class 1 Recall Notice - FDA]