Device recall
Z-0577-2018: Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are…
FDA device recall · Class II · Smiths Medical ASD, Inc.
Key facts
| Recall number (Z-number) | Z-0577-2018 |
|---|---|
| Recall event | 79045 |
| Product | Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag. |
| Product code | JOH |
| Recalling firm | Smiths Medical ASD, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 24, 2020 |
| FEI number | 1824231 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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