Device recall
Z-1948-2009: BARD Simpulse" SOLO System with Soft Splash Shield Tip Product Code: 0067590…
FDA device recall · Class II · Davol, Inc., Sub. C. R. Bard, Inc.
Key facts
| Recall number (Z-number) | Z-1948-2009 |
|---|---|
| Recall event | 52768 |
| Product | BARD Simpulse" SOLO System with Soft Splash Shield Tip Product Code: 0067590. The Simpulse SOLO Suction/Irrigator is designed to provide controlled powered irrigation during open orthopedic and general surgical procedures and for the cleansing of burns or wounds. Appropriate fluids for use include… |
| Product code | FHQ |
| Recalling firm | Davol, Inc., Sub. C. R. Bard, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 17, 2016 |
| FEI number | 1213643 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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