Recall Z-0022-04 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Vital Concepts, Inc.
HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
| 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 | 196 |
| Distribution | Arizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan |
| FDA record | Open on fda.gov |