Recall Class: Class I
Date Recall Initiated: October 10, 2014
The recalled devices were manufactured and distributed from July 2012 to August 2014.
See related Class I Recall.
Use: The Gel-E Donut and Squishon 2 gel-filled devices are used in hospitals, under the supervision of a caregiver, to support and cradle an infant’s head and/or body. The round shape of the Gel-E Donut helps ease pressure caused by long periods of stillness or other conditions where frequent moving is not suggested. The rectangular shape of the Squishon 2 provides support to the stomach area when an infant is lying face down (prone position) and also allows for head movement.
Recalling Firm:
Children’s Medical Ventures LLC, part of Philips Medical Systems, Inc.
300 Minuteman Road
Andover, Massachusetts 01810
Reason for Recall:
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.
Public Contact: Customers who have questions about this recall or require additional information or support may contact their local Philips representative.
FDA District: New England District Office
More Information about this Recall:Â
Philips Healthcare sent an Urgent – Field Safety Notice dated October 10, 2014 which outlined the problem and the steps to be taken.
Customers, end-users, and distributors should follow these steps:
- Stop using all Gel-E Donut and Squishon 2 devices, even if mold is not visible.
- Take an inventory of all Gel-E Donut and Squishon 2 devices in your possession.
- Complete the reply form enclosed with the Urgent – Field Safety Notice.
- Email the completed reply form to [email protected] or fax it to 1-404-855-4900.
- Return the reply form even if you do not have any inventory of the recalled devices or if you responded to the previous recall.
- Dispose of all Gel-E-Donut and Squishon 2 devices in your inventory, even if mold is not visible.
- Do not return any of these recalled devices to Philips Healthcare.
About Class I Recalls:
Class 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.