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.
This recall has been terminated (originally issued December 16, 2014).
- Company
- Philips Medical Systems, Inc.
- Recall Initiated
- October 10, 2014
- Posted
- December 16, 2014
- Terminated
- November 29, 2016
- Recall Number
- Z-0206-2015
- Quantity
- 336,695 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Mold on gel filled Gel-E and Squishon products
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.
Lot / Code Info
All lot codes
Root 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 Further, the Gel-E Donut and Squishon 2 products will be withdrawn from the market.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.