USFDA: Class I Medical Device Recall: Children’s Medical Ventures, Gel-E Donut and Squishon 2 - Possibility of Mold

Children’s Medical Ventures Gel-E Donut and Squishon 2: Class 1 Recall - Possibility of Mold

Date Recall Initiated: May 28, 2014

Product Model Numbers 

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

AUDIENCE:Pediatrics, Risk Manager

ISSUE: FDA and Children’s 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 infant’s 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, Children’s Medical Ventures sent an “Urgent–Field 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/Children’s Medical Ventures to correct the problem.

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

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

Read the MedWatch safety alert including a link to the Recall Notice at:

http://www.fda.gov/Safety/MedWatch/ucm411089.htm

About Class I RecallsClass I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.