FDAnews Device Daily Bulletin
Quality / Medical Devices / Postmarket Safety / Commercial Operations

Philips Medical Recalls Infant Gel Cushion Support Products

Nov. 18, 2014
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Children’s Medical Ventures, a Philips Healthcare subsidiary, said Friday that it is voluntarily recalling all models of its Gel-E Donut gel pillows and Squishon 2 gel cushions due to potential mold contamination, which could be transferred to patient environments once the outer pack is opened. The problem could lead to a superficial or life-threatening fungal infection.

The Monroeville, Pa., devicemaker initially recalled some products in May after mold contamination occurred during the manufacturing process. At the time of the first recall, Children’s Medical Ventures implemented a process to reduce the presence of viable mold on Gel-E and Squishon products prior to shipment. However, since then, the company has received a new report of mold, spurring a broader recall.

The current recall includes 336,695 units manufactured and distributed worldwide between July 2012 and August 2014.

Children’s Medical Ventures is asking customers to discontinue use and dispose of all Gel-E Donut gel pillows and Squishon 2 gel cushions in their facility, even if there is no visible mold. Customers will receive credit for the scrapped products once they return a reply form indicating that these actions have been completed.

View the recall notice at http://www.fdanews.com/11-17-14-PhilipsRecall.pdf. — Kellen Owings

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