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U.S. Department of Health and Human Services

Class 1 Device Recall GelE Donut, Squishon 2

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 Class 1 Device Recall GelE Donut, Squishon 2see related information
Date Initiated by FirmMay 28, 2014
Date PostedAugust 20, 2014
Recall Status1 Terminated 3 on November 29, 2016
Recall NumberZ-2192-2014
Recall Event ID 68443
Product Classification Protector, skin pressure - Product Code FMP
ProductGel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.
Code Information All lots of models: 92025-A, 92025-B, 92025-C, 91033-2
Recalling Firm/
Manufacturer		 Childrens Medical Ventures
191 Wyngate Dr
Monroeville PA 15146-3045
For Additional Information ContactCustomer Support
412-380-8881
Manufacturer Reason
for Recall		The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fungi, which are commonly found molds.
FDA Determined
Cause 2		Material/Component Contamination
ActionChildrens Medical Ventures sent an Urgent Medical Device Recall letter dated May 28, 2014, to affected customers via UPS. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to review entire inventory and inspect for signs of visible mold, do not open the packaging to do the inspection, the mold should be seen through the transparent outer packing, complete and return the reply form provided on the last page of the letter, dispose of any product containing mold per your facilitys environmental guidelines, do not return any product to your Distributor or to Philips/Childrens Medical Ventures.and credit for disposed product will be given. If you need any further information or support concerning this problem, please contact your Distributor at the following phone number:
Quantity in Commerce332,649
DistributionWorldwide Distribution - USA (nationwide) including the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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