Safety

Gel-E Donut and Squishon 2 Products by Children’s Medical Ventures: Recall - Potential Mold Contamination

UPDATED 12/02/2014. Recall Classified as Class I. Since Philips Healthcare’s May 2014 recall, the firm has received 12 new complaints of visible mold on their devices, including one injury.

[Posted 11/14/2014]

AUDIENCE: Risk Manager

ISSUE: Children’s Medical Ventures, a Philips Healthcare business, announced today a recall of all Gel-E Donut gel pillow and Squishon 2 gel cushion products due to potential mold contamination of the products.

In May 2014, Children’s Medical Ventures initiated a recall due to mold contamination of some products, which occurred during the manufacturing process. The mold types detected on the products have been identified as types which are commonly found in indoor and outdoor environments. There is potential for the mold to be transferred to patient environments once the outer pack is opened. There is the possibility of fungal infection should patients come in contact with the mold, which could be superficial or invasive and life threatening.

BACKGROUND: The Children’s Medical Ventures Gel-E Donut gel pillow and Squishon 2 gel cushions are intended to help support an infant’s head or body in a hospital environment. The products are intended to be used in Neonatal Intensive Care Units (NICU), Pediatric Intensive Care Units (PICU), and neonatal care centers.

Refer to the firm press release for a listing of recalled model numbers and quantities.

RECOMMENDATION: Customers are being asked to discontinue use and dispose of all Gel-E Donut gel pillow and Squishon 2 gel cushion products in their facility, even if mold is not visible. Customers who have questions about the recall or require further information or support concerning this issue, may contact their local Philips representative at (770) 510-4681 or (770) 510-4684.

Health care providers and consumers may report adverse events or quality problems experienced with the use of any Main Street products to the FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

[12/01/2014 - Recall Notice - FDA]
[11/14/2014 - Firm Press Release - Philips Healthcare]

Page Last Updated: 12/02/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.