Recall Z-0025-04 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Vital Concepts, Inc.
Irrigation Aspiration System for Nezhat Dorsey Type Pumps with 33 cm Probe, and Tubing, Disposable (single use only), sterile, latex free. Catalog # 55050. HYDRO-PRO brand labeled as sold by 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 | 120 |
| Distribution | Arizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan |
| FDA record | Open on fda.gov |