| Class 1 Device Recall Philips/Childrens Medical Venture |  |
Date Initiated by Firm | October 10, 2014 |
Date Posted | December 16, 2014 |
Recall Status1 |
Terminated 3 on November 29, 2016 |
Recall Number | Z-0206-2015 |
Recall Event ID |
69568 |
Product Classification |
Protector, skin pressure - Product Code FMP
|
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. |
Code Information |
All lot codes |
Recalling Firm/ Manufacturer |
Philips Medical Systems, Inc. 3000 Minuteman Rd Andover MA 01810-1032
|
For Additional Information Contact | 978-687-1501 |
Manufacturer Reason for Recall | Mold on gel filled Gel-E and Squishon products |
FDA Determined Cause 2 | Material/Component Contamination |
Action | 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 Further, the Gel-E Donut and Squishon 2 products will be withdrawn from the market.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. |
Quantity in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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