—#130963

Product

Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body.

FDA product code: FMP — Protector, Skin Pressure
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: All lot codes

Why it was recalled

Mold on gel filled Gel-E and Squishon products

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

Philips Healthcare/Children's Medical Ventures issued a Medical Device Recall Letter dated Oct 10, 2014. Customers were asked to discontinue use and dispose of all product in their facility, even if mold is not visible. Following these actions, customers will be asked to return a reply form indicating that these actions have been completed. Customers will be given credit for all disposed products. Further, the Gel-E Donut and Squishon 2 products will be withdrawn from the market. Customers with questions were instructed to contact their Philips/Children's Medical Ventures representative. For questions regarding this recall call 978-687-1501.

Recalling firm

Firm: Philips Medical Systems, Inc.
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to: Canada, Australia, Austria, Belgium, France, Germany, Iceland, Ireland, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Portugal, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, and the United Kingdom.

Timeline

Recall initiated: 2014-10-10
Posted by FDA: 2014-12-16
Terminated: 2016-11-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130963. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.