Recall Z-0206-2015
Philips Medical Systems, Inc. · initiated October 10, 2014
Class I – dangerous or defective products that could cause serious health problems or death
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.
Codes / lots: All lot codes
Reason for recall
Mold on gel filled Gel-E and Squishon products
FDA-determined cause: Material/Component Contamination
Action taken
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 Further, the Gel-E Donut and Squishon 2 products will be withdrawn from the market.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.
Details
- Recall number
- Z-0206-2015
- Initiated
- October 10, 2014
- Posted by FDA
- December 16, 2014
- Terminated
- November 29, 2016
- Product code
- FMP – Protector, Skin Pressure
- Quantity
- 336,695 units
- Distribution
- 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.
- Recalling firm
- Philips Medical Systems, Inc., Andover, MA