Device recall
Z-2192-2014: Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to…
FDA device recall · Class I · Childrens Medical Ventures
Key facts
| Recall number (Z-number) | Z-2192-2014 |
|---|---|
| Recall event | 68443 |
| Product | Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone… |
| Product code | FMP |
| Recalling firm | Childrens Medical Ventures |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 29, 2016 |
| FEI number | 3007056120 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database