Recall Z-0206-2015— Philips Medical Systems, Inc.
Class I · Terminated
Class I FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-10-10, terminated 2016-11-29. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Mold on gel filled Gel-E and Squishon products.
- Recalling firm
- Philips Medical Systems, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-10-10
- Terminated
- 2016-11-29
- Firm location
- Andover, MA, United States
Product description
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.
Reason for recall
Mold on gel filled Gel-E and Squishon products
Data sourced from openFDA. This site is unofficial and independent of the FDA.