Recall Z-0023-04 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Vital Concepts, Inc.
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
| Date | Oct 15, 2003 (initiated Jul 11, 2003) |
| Status | Terminated |
| Reason | The suction valve may become stuck in the 'suction on' position under vacuum. |
| Root cause | Other |
| Action | A request for product return was sent to each customer beginning on July 11, 2003. |
| Quantity | 288 |
| Distribution | Arizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan |
| FDA record | Open on fda.gov |