Device recall
Z-1566-2016: PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High…
FDA device recall · Class II · Stryker Endoscopy
Key facts
| Recall number (Z-number) | Z-1566-2016 |
|---|---|
| Recall event | 73674 |
| Product | PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 The Pneumo Sure XL High Flow Insufflator is a device… |
| Product code | HIF |
| Recalling firm | Stryker Endoscopy |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 14, 2016 |
| 510(k) numbers | K063367 |
| FEI number | 2936485 |
At a glance
- 1–9 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