Device recall
Z-0912-2011: Stryker Instruments, SmartPump Tourniquet System, Dual Channel Tourniquet Pump…
FDA device recall · Class II · Stryker Instruments Div. of Stryker Corporation
Key facts
| Recall number (Z-number) | Z-0912-2011 |
|---|---|
| Recall event | 56624 |
| Product | Stryker Instruments, SmartPump Tourniquet System, Dual Channel Tourniquet Pump, REF 5920-011-000, Rx only. Intended to be used to temporarily occlude or decrease blood flow in a patient extremity during a surgical procedure of that extremity. |
| Product code | KCY |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 16, 2011 |
| 510(k) numbers | K924273 |
| FEI number | 1811755 |
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