Device recall
Z-0335-2018: Intellicuff Standalone (PN 951001) Used to continuously measure and…
FDA device recall · Class II · Hamilton Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0335-2018 |
|---|---|
| Recall event | 77617 |
| Product | Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates. |
| Product code | BSK |
| Recalling firm | Hamilton Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K150893 |
| FEI number | 2937708 |
At a glance
- 1–9 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