Medical Device Safety and Recalls: Philips / Children's Medical Ventures, Gel-E Donut and Squishon 2 - Possibility of Mold

[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]

 



Title: Medical Device Safety and Recalls: Philips / Children's Medical Ventures, Gel-E Donut and Squishon 2 - Possibility of Mold

A recall has been issued for Philips / Children's Medical Ventures, Gel-E Donut and Squishon 2 for the possibility of mold.  Since Philips Healthcare’s May 2014 recall, the firm has received 12 new complaints of visible mold on their devices, including one injury.

Two commonly-found molds were detected: Cladosporium and Penicillium Fungi. Cladosporium has been known to cause several different types of serious infections, including skin, eye, sinus, and brain infections especially in weakened or critically ill patients. Cladosporium and Penicillium Fungi can also cause difficulty in breathing or an allergic reaction.

Neonatal intensive care unit (NICU) patients and pediatric intensive care unit (PICU) patients are much more sensitive to molds and once the outer packaging is opened, there is also the potential for the mold to be transferred to the NICU and PICU.

The use of affected product may cause serious adverse health consequences, including death.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm425260.htm


This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 Powered by GovDelivery

[Index of Archives]     [CDC News]     [NIH News]     [USDA News]     [Steve's Art]     [Camping in Yosemite]     [PhotoForum]     [SB Lupus]     [STB]

  Powered by Linux