Device recall
Z-0023-04: HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use…
FDA device recall · Class II · Vital Concepts, Inc.
Key facts
| Recall number (Z-number) | Z-0023-04 |
|---|---|
| Recall event | 27131 |
| Product | HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH |
| Product code | GCY |
| Recalling firm | Vital Concepts, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 12, 2004 |
| 510(k) numbers | K934382, K960616 |
| FEI number | 1000115375 |
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