Device recall
Z-1389-2016: Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in…
FDA device recall · Class III · Cygnus Medical
Key facts
| Recall number (Z-number) | Z-1389-2016 |
|---|---|
| Recall event | 73568 |
| Product | Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch). |
| Product code | MNL |
| Recalling firm | Cygnus Medical |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 23, 2016 |
| FEI number | 3001451466 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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