Device recall
Z-2640-2020: Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE…
FDA device recall · Class II · EHOB, Inc.
Key facts
| Recall number (Z-number) | Z-2640-2020 |
|---|---|
| Recall event | 85870 |
| Product | Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the hospital journey. Through immersion and envelopment, the WAFFLE Overlay is designed to offload the… |
| Product code | FMP |
| Recalling firm | EHOB, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 25, 2021 |
| FEI number | 1832066 |
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