Device recall
Z-0835-2018: StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER…
FDA device recall · Class II · Stryker Corporation
Key facts
| Recall number (Z-number) | Z-0835-2018 |
|---|---|
| Recall event | 78668 |
| Product | StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip… |
| Product code | GCJ |
| Recalling firm | Stryker Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 29, 2024 |
| 510(k) numbers | K934094, K954726 |
| FEI number | 2936485 |
At a glance
- 1–9 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